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VS 8 Vital Signs Monitor

Model VS 8 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · DI 06936415973650

MWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) · Class II · 21 CFR 870.2300

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.

24682019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1.25/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 1.4/device2019-06: 0 reports for this device; peer average 1.29/device2019-07: 0 reports for this device; peer average 1.25/device2019-08: 0 reports for this device; peer average 1.33/device2019-09: 0 reports for this device; peer average 1.33/device2019-10: 0 reports for this device; peer average 2/device2019-11: 0 reports for this device; peer average 1.29/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1.4/device2020-03: 0 reports for this device; peer average 1.5/device2020-04: 0 reports for this device; peer average 1.33/device2020-05: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 1.57/device2020-07: 0 reports for this device; peer average 2/device2020-08: 0 reports for this device; peer average 2.5/device2020-09: 0 reports for this device; peer average 1.5/device2020-10: 0 reports for this device; peer average 1.83/device2020-11: 0 reports for this device; peer average 1.8/device2020-12: 0 reports for this device; peer average 1.33/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1.4/device2021-04: 0 reports for this device; peer average 2.17/device2021-05: 0 reports for this device; peer average 2.5/device2021-06: 0 reports for this device; peer average 1.25/device2021-07: 0 reports for this device; peer average 1.89/device2021-08: 0 reports for this device; peer average 2.43/device2021-09: 0 reports for this device; peer average 1.86/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 1.75/device2021-12: 0 reports for this device; peer average 1.56/device2022-01: 0 reports for this device; peer average 1.27/device2022-02: 0 reports for this device; peer average 1.6/device2022-03: 0 reports for this device; peer average 1.17/device2022-04: 0 reports for this device; peer average 1.6/device2022-05: 0 reports for this device; peer average 2.4/device2022-06: 0 reports for this device; peer average 1.67/device2022-07: 0 reports for this device; peer average 1.25/device2022-08: 0 reports for this device; peer average 1.67/device2022-09: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 1.63/device2022-11: 0 reports for this device; peer average 1.67/device2022-12: 0 reports for this device; peer average 1.86/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 2.25/device2023-03: 0 reports for this device; peer average 3.25/device2023-04: 0 reports for this device; peer average 3.78/device2023-05: 0 reports for this device; peer average 1.2/device2023-06: 0 reports for this device; peer average 2.25/device2023-07: 0 reports for this device; peer average 1.67/device2023-08: 0 reports for this device; peer average 2.86/device2023-09: 0 reports for this device; peer average 3.4/device2023-10: 0 reports for this device; peer average 1.8/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1.5/device2024-01: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 2.8/device2024-03: 0 reports for this device; peer average 4.67/device2024-04: 0 reports for this device; peer average 1.33/device2024-05: 0 reports for this device; peer average 3.17/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 1.71/device2024-08: 0 reports for this device; peer average 3/device2024-09: 0 reports for this device; peer average 2.2/device2024-10: 0 reports for this device; peer average 2.8/device2024-11: 0 reports for this device; peer average 1.57/device2024-12: 0 reports for this device; peer average 7.2/device2025-01: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 2.67/device2025-03: 0 reports for this device; peer average 1.6/device2025-04: 0 reports for this device; peer average 2.43/device2025-05: 0 reports for this device; peer average 4.5/device2025-06: 0 reports for this device; peer average 5.33/device2025-07: 0 reports for this device; peer average 4.4/device2025-08: 0 reports for this device; peer average 5/device2025-09: 0 reports for this device; peer average 2.5/device2025-10: 0 reports for this device; peer average 6.4/device2025-11: 0 reports for this device; peer average 3.57/device2025-12: 0 reports for this device; peer average 2.77/device2026-01: 0 reports for this device; peer average 2.29/device2026-02: 0 reports for this device; peer average 2.86/device2026-03: 0 reports for this device; peer average 4.83/device2026-04: 0 reports for this device; peer average 7.17/device2026-05: 0 reports for this device; peer average 7.54/device2026-06: 0 reports for this device; peer average 7.92/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0201
2019-0301.25
2019-0402
2019-0501.4
2019-0601.29
2019-0701.25
2019-0801.33
2019-0901.33
2019-1002
2019-1101.29
2019-1201
2020-0101
2020-0201.4
2020-0301.5
2020-0401.33
2020-0501.5
2020-0601.57
2020-0702
2020-0802.5
2020-0901.5
2020-1001.83
2020-1101.8
2020-1201.33
2021-0101
2021-0201
2021-0301.4
2021-0402.17
2021-0502.5
2021-0601.25
2021-0701.89
2021-0802.43
2021-0901.86
2021-1002
2021-1101.75
2021-1201.56
2022-0101.27
2022-0201.6
2022-0301.17
2022-0401.6
2022-0502.4
2022-0601.67
2022-0701.25
2022-0801.67
2022-0902
2022-1001.63
2022-1101.67
2022-1201.86
2023-0102
2023-0202.25
2023-0303.25
2023-0403.78
2023-0501.2
2023-0602.25
2023-0701.67
2023-0802.86
2023-0903.4
2023-1001.8
2023-1101
2023-1201.5
2024-0102
2024-0202.8
2024-0304.67
2024-0401.33
2024-0503.17
2024-0602
2024-0701.71
2024-0803
2024-0902.2
2024-1002.8
2024-1101.57
2024-1207.2
2025-0101
2025-0202.67
2025-0301.6
2025-0402.43
2025-0504.5
2025-0605.33
2025-0704.4
2025-0805
2025-0902.5
2025-1006.4
2025-1103.57
2025-1202.77
2026-0102.29
2026-0202.86
2026-0304.83
2026-0407.17
2026-0507.54
2026-0607.92
This device (reports/month)Average device in MWI (reports/device/month)

Regulatory clearances

  • K221267 SESE 2022-12-15 (k number procode)
  • K211475 SESE 2021-10-05 (k number procode)

Predicate lineage

K211475 — cites (transitively): K011291 (d1), K182075 (d1), K182821 (d1), K191769 (d1), K193391 (d1), K042346 (d2), K042536 (d2), K051212 (d2), K170712 (d2), K020550 (d2), K062098 (d2), K070791 (d2), K072235 (d2), K091834 (d2), K092449 (d2), K150352 (d2), K153448 (d2), K172226 (d2), K183238 (d2), K101521 (d3), K132026 (d3), K143195 (d3), K132038 (d3), K152902 (d3), K101600 (d3), K103646 (d3), K111905 (d3), K113125 (d3), K150632 (d3), K161531 (d3), K162607 (d3), K170876 (d3), K172482 (d3), K003621 (d4), K030738 (d4), K073376 (d4), K033715 (d4), K041741 (d4), K081937 (d4), K090360 (d4), K040357 (d4), K062392 (d4), K063725 (d4), K081793 (d4), K083517 (d4), K100939 (d4), K123074 (d4), K132037 (d4), K132075 (d4), K132036 (d4), K132662 (d4), K142601 (d4), K150310 (d4), K150975 (d4), K151681 (d4), K060576 (d4), K141518 (d4), K080192 (d5), K091786 (d5), K102562 (d5), K111933 (d5), K121806 (d5), K123581 (d5), K130320 (d5), K031760 (d5), K021788 (d5), K030038 (d5), K031481 (d5), K032858 (d5), K040304 (d5), K041235 (d5), K042845 (d5), K050141 (d5), K050762 (d5), K051106 (d5), K052801 (d5), K053522 (d5), K060221 (d5), K060541 (d5), K061052 (d5), K061610 (d5), K062283 (d5), K063315 (d5), K071426 (d5), K072020 (d5), K082633 (d5), K091927 (d5), K093268 (d5), K101449 (d5), K110474 (d5), K110622 (d5), K113441 (d5), K113657 (d5), K120366 (d5), K120657 (d5), K122439 (d5), K130849 (d5), K131872 (d5), K141015 (d5), K021778 (d6), K033444 (d6), K033513 (d6), K171426 (d6), K172020 (d6), K013199 (d6), K051896 (d6), K083325 (d6), K093260 (d6), K033296 (d6), K080238 (d6), K092838 (d6), K101896 (d6), K012891 (d6), K120773 (d6), K052961 (d6), K082583 (d6), K131861 (d7), K141077 (d7), K081888 (d7), K101923 (d7), P960025 (d7), K081917 (d8), K090993 (d8) — cited as predicate by K221267, K232962, K242728

K221267 — cites (transitively): K011291 (d1), K211475 (d1), K182075 (d2), K182821 (d2), K191769 (d2), K193391 (d2), K042346 (d3), K042536 (d3), K051212 (d3), K170712 (d3), K020550 (d3), K062098 (d3), K070791 (d3), K072235 (d3), K091834 (d3), K092449 (d3), K150352 (d3), K153448 (d3), K172226 (d3), K183238 (d3), K101521 (d4), K132026 (d4), K143195 (d4), K132038 (d4), K152902 (d4), K101600 (d4), K103646 (d4), K111905 (d4), K113125 (d4), K150632 (d4), K161531 (d4), K162607 (d4), K170876 (d4), K172482 (d4), K003621 (d5), K030738 (d5), K073376 (d5), K033715 (d5), K041741 (d5), K081937 (d5), K090360 (d5), K040357 (d5), K062392 (d5), K063725 (d5), K081793 (d5), K083517 (d5), K100939 (d5), K123074 (d5), K132037 (d5), K132075 (d5), K132036 (d5), K132662 (d5), K142601 (d5), K150310 (d5), K150975 (d5), K151681 (d5), K060576 (d5), K141518 (d5), K080192 (d6), K091786 (d6), K102562 (d6), K111933 (d6), K121806 (d6), K123581 (d6), K130320 (d6), K031760 (d6), K021788 (d6), K030038 (d6), K031481 (d6), K032858 (d6), K040304 (d6), K041235 (d6), K042845 (d6), K050141 (d6), K050762 (d6), K051106 (d6), K052801 (d6), K053522 (d6), K060221 (d6), K060541 (d6), K061052 (d6), K061610 (d6), K062283 (d6), K063315 (d6), K071426 (d6), K072020 (d6), K082633 (d6), K091927 (d6), K093268 (d6), K101449 (d6), K110474 (d6), K110622 (d6), K113441 (d6), K113657 (d6), K120366 (d6), K120657 (d6), K122439 (d6), K130849 (d6), K131872 (d6), K141015 (d6), K021778 (d7), K033444 (d7), K033513 (d7), K171426 (d7), K172020 (d7), K013199 (d7), K051896 (d7), K083325 (d7), K093260 (d7), K033296 (d7), K080238 (d7), K092838 (d7), K101896 (d7), K012891 (d7), K120773 (d7), K052961 (d7), K082583 (d7), K131861 (d8), K141077 (d8), K081888 (d8), K101923 (d8), P960025 (d8) — cited as predicate by K233038

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