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M8 Elite Portable Diagnostic Ultrasound System

Model M8 Elite · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · DI 06944904095653

IYN — System, Imaging, Pulsed Doppler, Ultrasonic · Class II · 21 CFR 892.1550

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

51116212019-01: 0 reports for this device; peer average 1.8/device2019-02: 0 reports for this device; peer average 2.33/device2019-03: 0 reports for this device; peer average 1.25/device2019-04: 0 reports for this device; peer average 1.71/device2019-05: 0 reports for this device; peer average 2.09/device2019-06: 0 reports for this device; peer average 4.75/device2019-07: 0 reports for this device; peer average 3.43/device2019-08: 0 reports for this device; peer average 2.11/device2019-09: 0 reports for this device; peer average 2.36/device2019-10: 0 reports for this device; peer average 3/device2019-11: 0 reports for this device; peer average 3.79/device2019-12: 0 reports for this device; peer average 3.28/device2020-01: 0 reports for this device; peer average 2.47/device2020-02: 0 reports for this device; peer average 5.8/device2020-03: 0 reports for this device; peer average 3.07/device2020-04: 0 reports for this device; peer average 2.85/device2020-05: 0 reports for this device; peer average 2.31/device2020-06: 0 reports for this device; peer average 2.81/device2020-07: 0 reports for this device; peer average 4.19/device2020-08: 0 reports for this device; peer average 2.75/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 3.89/device2020-11: 0 reports for this device; peer average 4.09/device2020-12: 0 reports for this device; peer average 6.5/device2021-01: 0 reports for this device; peer average 7.56/device2021-02: 0 reports for this device; peer average 5.19/device2021-03: 0 reports for this device; peer average 9.81/device2021-04: 0 reports for this device; peer average 4.15/device2021-05: 0 reports for this device; peer average 7.09/device2021-06: 0 reports for this device; peer average 7.08/device2021-07: 0 reports for this device; peer average 10.21/device2021-08: 0 reports for this device; peer average 8.23/device2021-09: 0 reports for this device; peer average 12.85/device2021-10: 0 reports for this device; peer average 5.33/device2021-11: 0 reports for this device; peer average 9.53/device2021-12: 0 reports for this device; peer average 11/device2022-01: 0 reports for this device; peer average 7.11/device2022-02: 0 reports for this device; peer average 9.62/device2022-03: 0 reports for this device; peer average 8.53/device2022-04: 0 reports for this device; peer average 10.86/device2022-05: 0 reports for this device; peer average 13.93/device2022-06: 0 reports for this device; peer average 10.43/device2022-07: 0 reports for this device; peer average 11.23/device2022-08: 0 reports for this device; peer average 5.71/device2022-09: 0 reports for this device; peer average 5.47/device2022-10: 0 reports for this device; peer average 5.33/device2022-11: 0 reports for this device; peer average 5.12/device2022-12: 0 reports for this device; peer average 5.8/device2023-01: 0 reports for this device; peer average 5.05/device2023-02: 0 reports for this device; peer average 5.13/device2023-03: 0 reports for this device; peer average 6.88/device2023-04: 0 reports for this device; peer average 4.38/device2023-05: 0 reports for this device; peer average 8.79/device2023-06: 0 reports for this device; peer average 4.52/device2023-07: 0 reports for this device; peer average 4.86/device2023-08: 0 reports for this device; peer average 8.29/device2023-09: 0 reports for this device; peer average 7/device2023-10: 0 reports for this device; peer average 6.84/device2023-11: 0 reports for this device; peer average 6.52/device2023-12: 0 reports for this device; peer average 6.58/device2024-01: 0 reports for this device; peer average 6.4/device2024-02: 0 reports for this device; peer average 4.27/device2024-03: 0 reports for this device; peer average 7.8/device2024-04: 0 reports for this device; peer average 7.13/device2024-05: 0 reports for this device; peer average 4.53/device2024-06: 0 reports for this device; peer average 6.67/device2024-07: 0 reports for this device; peer average 5.43/device2024-08: 0 reports for this device; peer average 5.41/device2024-09: 0 reports for this device; peer average 7.08/device2024-10: 0 reports for this device; peer average 7.36/device2024-11: 0 reports for this device; peer average 5.04/device2024-12: 0 reports for this device; peer average 13.5/device2025-01: 0 reports for this device; peer average 4.73/device2025-02: 0 reports for this device; peer average 4.39/device2025-03: 0 reports for this device; peer average 6.89/device2025-04: 0 reports for this device; peer average 3.33/device2025-05: 0 reports for this device; peer average 4/device2025-06: 0 reports for this device; peer average 4.19/device2025-07: 0 reports for this device; peer average 4.38/device2025-08: 0 reports for this device; peer average 4.9/device2025-09: 0 reports for this device; peer average 5.62/device2025-10: 0 reports for this device; peer average 10.77/device2025-11: 0 reports for this device; peer average 13.93/device2025-12: 0 reports for this device; peer average 21.04/device2026-01: 0 reports for this device; peer average 12.65/device2026-02: 0 reports for this device; peer average 7.18/device2026-03: 0 reports for this device; peer average 8.91/device2026-04: 0 reports for this device; peer average 13.26/device2026-05: 0 reports for this device; peer average 19.59/device2026-06: 0 reports for this device; peer average 17.26/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.8
2019-0202.33
2019-0301.25
2019-0401.71
2019-0502.09
2019-0604.75
2019-0703.43
2019-0802.11
2019-0902.36
2019-1003
2019-1103.79
2019-1203.28
2020-0102.47
2020-0205.8
2020-0303.07
2020-0402.85
2020-0502.31
2020-0602.81
2020-0704.19
2020-0802.75
2020-0902
2020-1003.89
2020-1104.09
2020-1206.5
2021-0107.56
2021-0205.19
2021-0309.81
2021-0404.15
2021-0507.09
2021-0607.08
2021-07010.21
2021-0808.23
2021-09012.85
2021-1005.33
2021-1109.53
2021-12011
2022-0107.11
2022-0209.62
2022-0308.53
2022-04010.86
2022-05013.93
2022-06010.43
2022-07011.23
2022-0805.71
2022-0905.47
2022-1005.33
2022-1105.12
2022-1205.8
2023-0105.05
2023-0205.13
2023-0306.88
2023-0404.38
2023-0508.79
2023-0604.52
2023-0704.86
2023-0808.29
2023-0907
2023-1006.84
2023-1106.52
2023-1206.58
2024-0106.4
2024-0204.27
2024-0307.8
2024-0407.13
2024-0504.53
2024-0606.67
2024-0705.43
2024-0805.41
2024-0907.08
2024-1007.36
2024-1105.04
2024-12013.5
2025-0104.73
2025-0204.39
2025-0306.89
2025-0403.33
2025-0504
2025-0604.19
2025-0704.38
2025-0804.9
2025-0905.62
2025-10010.77
2025-11013.93
2025-12021.04
2026-01012.65
2026-0207.18
2026-0308.91
2026-04013.26
2026-05019.59
2026-06017.26
This device (reports/month)Average device in IYN (reports/device/month)

Regulatory clearances

  • K171034 SESE 2017-07-10 (k number procode)

Predicate lineage

K171034 — cites (transitively): K093713 (d1), K152543 (d1), K161525 (d1), K162267 (d1), K170277 (d1), K970514 (d1), K071204 (d2), K882383 (d2), K121062 (d2), K132913 (d2), K141010 (d2), K143472 (d2), K150080 (d2), K150204 (d2), K131690 (d2), K152763 (d2), K160381 (d2), K153529 (d2), K160807 (d2), K121010 (d3), K122327 (d3), K132341 (d3), K131609 (d3), K132779 (d3), K132335 (d3), K142160 (d3), K113758 (d3), K143089 (d3), K150478 (d3), K151663 (d3), K152962 (d3), K151175 (d3), K043535 (d3), K081661 (d3), K120321 (d3), K121498 (d3), K130159 (d3), K132165 (d3), K132304 (d3), K093563 (d4), K103583 (d4), K103677 (d4), K113647 (d4), K053610 (d4), K040227 (d4), K042293 (d4), K040762 (d4), K042540 (d4), K070792 (d4), K120525 (d4), K130499 (d4), K108114 (d4), K123254 (d4), K101236 (d4), K120201 (d4), K113690 (d4), K123503 (d4), K130695 (d4), K123564 (d4), K132274 (d4), K130739 (d4), K132861 (d4), K133329 (d4), K141620 (d4), K112339 (d4), K133505 (d4), K142466 (d4), K143264 (d4), K150249 (d4), K021966 (d4), K130803 (d4), K130881 (d4), K131164 (d4), K103397 (d4), K023877 (d5), K030455 (d5), K072786 (d5), K061682 (d5), K092159 (d5), K093714 (d5), K093849 (d5), K032974 (d5), K050240 (d5), K052410 (d5), K060542 (d5), K060993 (d5), K101041 (d5), K053069 (d5), K072365 (d5), K091374 (d5), K092271 (d5), K063085 (d5), K101757 (d5), K112596 (d5), K102388 (d5), K081154 (d5), K100919 (d5), K120699 (d5), K122010 (d5), K111582 (d5), K122921 (d5), K121138 (d5), K121329 (d5), K112255 (d5), K122825 (d5), K122583 (d5), K130903 (d5), K101455 (d5), K050846 (d5), K132228 (d5), K120703 (d5), K141641 (d5), K070813 (d6), K043524 (d6), K020789 (d6), K060087 (d6), K094623 (d6), K043559 (d6), K071134 (d6), K082098 (d6), K092058 (d6), K033139 (d6), K092079 (d6), K091970 (d6), K102041 (d6), K033650 (d6), K042593 (d6), K071234 (d6), K081148 (d6), K082142 (d6), K090334 (d6), K093812 (d6), K992631 (d6), K073709 (d6), K082326 (d6), K101091 (d6), K022567 (d6), K032114 (d6), K063803 (d6), K111674 (d6), K083001 (d6), K090912 (d6), K100830 (d6), K102991 (d6), K031066 (d6), K123185 (d6), K130703 (d6), K072797 (d7), K022858 (d7), K062247 (d7), K072164 (d7), K090855 (d7) — cited as predicate by K172860, K172970, K173369, K173471, K180912, K181637, K182636, K192152, K200001, K200643, K203391, K210416

K210416 — cites (transitively): K171034 (d1), K192152 (d1), K192410 (d1), K200001 (d1), K201693 (d1), K203391 (d1), K093713 (d2), K152543 (d2), K161525 (d2), K162267 (d2), K170277 (d2), K970514 (d2), K171233 (d2), K173471 (d2), K181637 (d2), K181985 (d2), K190206 (d2), K160559 (d2), K171891 (d2), K181783 (d2), K180599 (d2), K180912 (d2), K183377 (d2), K071204 (d3), K882383 (d3), K121062 (d3), K132913 (d3), K141010 (d3), K143472 (d3), K150080 (d3), K150204 (d3), K142368 (d3), K131690 (d3), K152763 (d3), K160381 (d3), K153529 (d3), K160807 (d3), K081386 (d3), K151175 (d3), K153277 (d3), K162269 (d3), K163077 (d3), K160184 (d3), K163690 (d3), K151028 (d3), K161706 (d3), K163596 (d3), K170714 (d3), K140254 (d3), K171579 (d3), K160162 (d3), K170445 (d3), K173555 (d3), K180535 (d3), K172342 (d3), K162845 (d3), K121010 (d4), K122327 (d4), K120234 (d4), K132341 (d4), K022928 (d4), K032503 (d4), K032875 (d4), K033311 (d4), K040719 (d4), K063518 (d4), K093466 (d4), K102901 (d4), K110673 (d4), K122537 (d4), K130206 (d4), K130247 (d4), K130308 (d4), K130881 (d4), K131946 (d4), K134016 (d4), K140443 (d4), K140639 (d4), K131609 (d4), K132779 (d4), K113690 (d4), K133533 (d4), K150249 (d4), K132335 (d4), K142160 (d4), K061961 (d4), K133905 (d4), K142008 (d4), K113758 (d4), K143089 (d4), K150478 (d4), K151663 (d4), K152962 (d4), K141675 (d4), K142472 (d4), K152567 (d4), K141639 (d4), K043535 (d4), K081661 (d4), K120321 (d4), K121498 (d4), K130159 (d4), K132165 (d4), K132304 (d4), K140318 (d4), K150087 (d4), K160078 (d4), K160277 (d4), K152309 (d4), K140030 (d4), K152545 (d4), K152758 (d4), K160182 (d4), K161047 (d4), K152195 (d4), K160524 (d4), K142323 (d4), K102991 (d4), K072786 (d5), K072164 (d5), K083001 (d5), K100830 (d5), K093563 (d5), K103583 (d5), K103677 (d5), K113647 (d5), K053610 (d5), K072285 (d5), K040227 (d5), K042293 (d5), K090196 (d5), K090197 (d5), K121138 (d5), K121329 (d5), K040762 (d5), K081518 (d5), K042540 (d5), K070792 (d5), K120525 (d5), K130499 (d5), K108114 (d5), K123254 (d5), K101236 (d5), K120201 (d5), K123503 (d5), K130695 (d5), K131527 (d5), K100931 (d5), K103152 (d5), K123828 (d5), K120699 (d5), K130058 (d5), K120741 (d5), K051308 (d5), K052805 (d5), K060827 (d5), K081794 (d5), K091009 (d5), K110688 (d5), K111032 (d5), K111302 (d5), K132231 (d5), K132466 (d5), K140677 (d5), K123564 (d5), K132274 (d5), K121063 (d5), K131514 (d5), K141093 (d5), K130739 (d5), K132861 (d5), K133329 (d5), K141620 (d5), K120703 (d5), K141641 (d5), K112339 (d5), K133505 (d5), K142466 (d5), K143264 (d5), K021966 (d5), K130803 (d5), K131164 (d5), K141261 (d5), K143452 (d5), K133431 (d5), K142443 (d5), K103397 (d5), K133034 (d5), K141067 (d5), K141768 (d5), K150949 (d5), K023877 (d6), K030455 (d6), K072797 (d6), K051837 (d6), K061682 (d6), K092159 (d6), K093714 (d6), K093849 (d6), K032974 (d6), K050240 (d6), K052410 (d6), K060542 (d6), K060993 (d6), K101041 (d6), K053069 (d6), K072365 (d6), K091374 (d6), K092271 (d6), K090107 (d6), K091763 (d6), K050326 (d6), K101605 (d6), K063085 (d6), K101757 (d6), K112596 (d6), K102388 (d6), K073709 (d6), K082326 (d6), K101091 (d6), K053435 (d6), K103649 (d6), K071985 (d6), K082374 (d6), K092079 (d6), K022567 (d6), K032114 (d6), K033650 (d6), K042593 (d6), K063803 (d6), K071234 (d6), K081148 (d6), K082142 (d6), K090334 (d6), K093812 (d6), K111674 (d6), K102041 (d6), K081154 (d6), K100919 (d6), K122010 (d6), K111582 (d6), K122921 (d6), K093395 (d6), K110207 (d6), K112255 (d6), K122825 (d6), K031663 (d6), K120221 (d6), K122583 (d6), K130903 (d6), K101455 (d6), K121384 (d6), K060907 (d6), K101874 (d6), K050846 (d6), K031066 (d6), K123185 (d6), K130703 (d6), K131267 (d6), K092619 (d6), K132942 (d6), K132228 (d6), K123806 (d6), K142517 (d6), K070813 (d7), K043524 (d7), K022858 (d7), K062247 (d7), K020789 (d7), K060087 (d7), K094623 (d7), K083882 (d7), K092058 (d7), K043559 (d7), K071134 (d7), K082098 (d7), K073297 (d7), K091970 (d7), K033139 (d7), K041916 (d7), K043196 (d7), K992631 (d7), K090912 (d7), K090855 (d7), K100402 (d7), K123209 (d7), K133761 (d7), K080555 (d8), K123992 (d8) — cited as predicate by K212265, K212900, K230768

K230768 — cites (transitively): K210416 (d1), K171034 (d2), K192152 (d2), K192410 (d2), K200001 (d2), K201693 (d2), K203391 (d2), K093713 (d3), K152543 (d3), K161525 (d3), K162267 (d3), K170277 (d3), K970514 (d3), K171233 (d3), K173471 (d3), K181637 (d3), K181985 (d3), K190206 (d3), K160559 (d3), K171891 (d3), K181783 (d3), K180599 (d3), K180912 (d3), K183377 (d3), K071204 (d4), K882383 (d4), K121062 (d4), K132913 (d4), K141010 (d4), K143472 (d4), K150080 (d4), K150204 (d4), K142368 (d4), K131690 (d4), K152763 (d4), K160381 (d4), K153529 (d4), K160807 (d4), K081386 (d4), K151175 (d4), K153277 (d4), K162269 (d4), K163077 (d4), K160184 (d4), K163690 (d4), K151028 (d4), K161706 (d4), K163596 (d4), K170714 (d4), K140254 (d4), K171579 (d4), K160162 (d4), K170445 (d4), K173555 (d4), K180535 (d4), K172342 (d4), K162845 (d4), K121010 (d5), K122327 (d5), K120234 (d5), K132341 (d5), K022928 (d5), K032503 (d5), K032875 (d5), K033311 (d5), K040719 (d5), K063518 (d5), K093466 (d5), K102901 (d5), K110673 (d5), K122537 (d5), K130206 (d5), K130247 (d5), K130308 (d5), K130881 (d5), K131946 (d5), K134016 (d5), K140443 (d5), K140639 (d5), K131609 (d5), K132779 (d5), K113690 (d5), K133533 (d5), K150249 (d5), K132335 (d5), K142160 (d5), K061961 (d5), K133905 (d5), K142008 (d5), K113758 (d5), K143089 (d5), K150478 (d5), K151663 (d5), K152962 (d5), K141675 (d5), K142472 (d5), K152567 (d5), K141639 (d5), K043535 (d5), K081661 (d5), K120321 (d5), K121498 (d5), K130159 (d5), K132165 (d5), K132304 (d5), K140318 (d5), K150087 (d5), K160078 (d5), K160277 (d5), K152309 (d5), K140030 (d5), K152545 (d5), K152758 (d5), K160182 (d5), K161047 (d5), K152195 (d5), K160524 (d5), K142323 (d5), K102991 (d5), K072786 (d6), K072164 (d6), K083001 (d6), K100830 (d6), K093563 (d6), K103583 (d6), K103677 (d6), K113647 (d6), K053610 (d6), K072285 (d6), K040227 (d6), K042293 (d6), K090196 (d6), K090197 (d6), K121138 (d6), K121329 (d6), K040762 (d6), K081518 (d6), K042540 (d6), K070792 (d6), K120525 (d6), K130499 (d6), K108114 (d6), K123254 (d6), K101236 (d6), K120201 (d6), K123503 (d6), K130695 (d6), K131527 (d6), K100931 (d6), K103152 (d6), K123828 (d6), K120699 (d6), K130058 (d6), K120741 (d6), K051308 (d6), K052805 (d6), K060827 (d6), K081794 (d6), K091009 (d6), K110688 (d6), K111032 (d6), K111302 (d6), K132231 (d6), K132466 (d6), K140677 (d6), K123564 (d6), K132274 (d6), K121063 (d6), K131514 (d6), K141093 (d6), K130739 (d6), K132861 (d6), K133329 (d6), K141620 (d6), K120703 (d6), K141641 (d6), K112339 (d6), K133505 (d6), K142466 (d6), K143264 (d6), K021966 (d6), K130803 (d6), K131164 (d6), K141261 (d6), K143452 (d6), K133431 (d6), K142443 (d6), K103397 (d6), K133034 (d6), K141067 (d6), K141768 (d6), K150949 (d6), K023877 (d7), K030455 (d7), K072797 (d7), K051837 (d7), K061682 (d7), K092159 (d7), K093714 (d7), K093849 (d7), K032974 (d7), K050240 (d7), K052410 (d7), K060542 (d7), K060993 (d7), K101041 (d7), K053069 (d7), K072365 (d7), K091374 (d7), K092271 (d7), K090107 (d7), K091763 (d7), K050326 (d7), K101605 (d7), K063085 (d7), K101757 (d7), K112596 (d7), K102388 (d7), K073709 (d7), K082326 (d7), K101091 (d7), K053435 (d7), K103649 (d7), K071985 (d7), K082374 (d7), K092079 (d7), K022567 (d7), K032114 (d7), K033650 (d7), K042593 (d7), K063803 (d7), K071234 (d7), K081148 (d7), K082142 (d7), K090334 (d7), K093812 (d7), K111674 (d7), K102041 (d7), K081154 (d7), K100919 (d7), K122010 (d7), K111582 (d7), K122921 (d7), K093395 (d7), K110207 (d7), K112255 (d7), K122825 (d7), K031663 (d7), K120221 (d7), K122583 (d7), K130903 (d7), K101455 (d7), K121384 (d7), K060907 (d7), K101874 (d7), K050846 (d7), K031066 (d7), K123185 (d7), K130703 (d7), K131267 (d7), K092619 (d7), K132942 (d7), K132228 (d7), K123806 (d7), K142517 (d7), K070813 (d8), K043524 (d8), K022858 (d8), K062247 (d8), K020789 (d8), K060087 (d8), K094623 (d8), K083882 (d8), K092058 (d8), K043559 (d8), K071134 (d8), K082098 (d8), K073297 (d8), K091970 (d8), K033139 (d8), K041916 (d8), K043196 (d8), K992631 (d8), K090912 (d8), K090855 (d8), K100402 (d8), K123209 (d8), K133761 (d8) — cited as predicate by K241432, K250228

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

  • NAI 2017-04-14 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 0 citations
  • VAI 2017-04-14 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. · 0 citations
  • VAI 2017-04-14 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. · 0 citations
  • NAI 2017-04-14 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 0 citations
  • VAI 2015-05-15 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 1 citations
  • VAI 2012-04-12 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 5 citations