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SpO2 Sensor

Model SHD-N, Neonate, disposable · Edan Instruments, Inc. · DI 06944413805408

DQA — Oximeter · Class II · 21 CFR 870.2700

UDILibrary device dossier · generated 2026-09-13 · 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.

91827362019-01: 0 reports for this device; peer average 10.5/device2019-02: 0 reports for this device; peer average 11.13/device2019-03: 0 reports for this device; peer average 8.57/device2019-04: 0 reports for this device; peer average 9.4/device2019-05: 0 reports for this device; peer average 8.47/device2019-06: 0 reports for this device; peer average 7.73/device2019-07: 0 reports for this device; peer average 8.03/device2019-08: 0 reports for this device; peer average 9.07/device2019-09: 0 reports for this device; peer average 12/device2019-10: 0 reports for this device; peer average 9.49/device2019-11: 0 reports for this device; peer average 8.85/device2019-12: 0 reports for this device; peer average 10.21/device2020-01: 0 reports for this device; peer average 9.41/device2020-02: 0 reports for this device; peer average 8.76/device2020-03: 0 reports for this device; peer average 8.97/device2020-04: 0 reports for this device; peer average 13.14/device2020-05: 0 reports for this device; peer average 9.03/device2020-06: 0 reports for this device; peer average 8.36/device2020-07: 0 reports for this device; peer average 8.15/device2020-08: 0 reports for this device; peer average 8.91/device2020-09: 0 reports for this device; peer average 10.35/device2020-10: 0 reports for this device; peer average 10.15/device2020-11: 0 reports for this device; peer average 11.16/device2020-12: 0 reports for this device; peer average 10.8/device2021-01: 0 reports for this device; peer average 10.02/device2021-02: 0 reports for this device; peer average 10.55/device2021-03: 0 reports for this device; peer average 14.58/device2021-04: 0 reports for this device; peer average 8.9/device2021-05: 0 reports for this device; peer average 7.47/device2021-06: 0 reports for this device; peer average 9.93/device2021-07: 0 reports for this device; peer average 8.43/device2021-08: 0 reports for this device; peer average 7.77/device2021-09: 0 reports for this device; peer average 7.44/device2021-10: 0 reports for this device; peer average 10.18/device2021-11: 0 reports for this device; peer average 10.54/device2021-12: 0 reports for this device; peer average 7.71/device2022-01: 0 reports for this device; peer average 7.26/device2022-02: 0 reports for this device; peer average 8.28/device2022-03: 0 reports for this device; peer average 11.32/device2022-04: 0 reports for this device; peer average 11.07/device2022-05: 0 reports for this device; peer average 15.27/device2022-06: 0 reports for this device; peer average 10.68/device2022-07: 0 reports for this device; peer average 7.27/device2022-08: 0 reports for this device; peer average 9.14/device2022-09: 0 reports for this device; peer average 12.08/device2022-10: 0 reports for this device; peer average 16.46/device2022-11: 0 reports for this device; peer average 9.11/device2022-12: 0 reports for this device; peer average 12.31/device2023-01: 0 reports for this device; peer average 10.07/device2023-02: 0 reports for this device; peer average 17.6/device2023-03: 0 reports for this device; peer average 19.41/device2023-04: 0 reports for this device; peer average 21.93/device2023-05: 0 reports for this device; peer average 21.78/device2023-06: 0 reports for this device; peer average 14.76/device2023-07: 0 reports for this device; peer average 27.83/device2023-08: 0 reports for this device; peer average 32.21/device2023-09: 0 reports for this device; peer average 32.73/device2023-10: 0 reports for this device; peer average 21.29/device2023-11: 0 reports for this device; peer average 31.3/device2023-12: 0 reports for this device; peer average 28.87/device2024-01: 0 reports for this device; peer average 26.92/device2024-02: 0 reports for this device; peer average 23.95/device2024-03: 0 reports for this device; peer average 30.02/device2024-04: 0 reports for this device; peer average 16.76/device2024-05: 0 reports for this device; peer average 18.2/device2024-06: 0 reports for this device; peer average 15.54/device2024-07: 0 reports for this device; peer average 26.88/device2024-08: 0 reports for this device; peer average 24.81/device2024-09: 0 reports for this device; peer average 30.13/device2024-10: 0 reports for this device; peer average 36.26/device2024-11: 0 reports for this device; peer average 26.81/device2024-12: 0 reports for this device; peer average 22.65/device2025-01: 0 reports for this device; peer average 28.25/device2025-02: 0 reports for this device; peer average 22/device2025-03: 0 reports for this device; peer average 27.79/device2025-04: 0 reports for this device; peer average 17.38/device2025-05: 0 reports for this device; peer average 14.64/device2025-06: 0 reports for this device; peer average 10.52/device2025-07: 0 reports for this device; peer average 10.23/device2025-08: 0 reports for this device; peer average 8.61/device2025-09: 0 reports for this device; peer average 9.3/device2025-10: 0 reports for this device; peer average 14.12/device2025-11: 0 reports for this device; peer average 8.46/device2025-12: 0 reports for this device; peer average 11.1/device2026-01: 0 reports for this device; peer average 11.34/device2026-02: 0 reports for this device; peer average 10.34/device2026-03: 0 reports for this device; peer average 11.79/device2026-04: 0 reports for this device; peer average 31.1/device2026-05: 0 reports for this device; peer average 15.68/device2026-06: 0 reports for this device; peer average 13.5/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01010.5
2019-02011.13
2019-0308.57
2019-0409.4
2019-0508.47
2019-0607.73
2019-0708.03
2019-0809.07
2019-09012
2019-1009.49
2019-1108.85
2019-12010.21
2020-0109.41
2020-0208.76
2020-0308.97
2020-04013.14
2020-0509.03
2020-0608.36
2020-0708.15
2020-0808.91
2020-09010.35
2020-10010.15
2020-11011.16
2020-12010.8
2021-01010.02
2021-02010.55
2021-03014.58
2021-0408.9
2021-0507.47
2021-0609.93
2021-0708.43
2021-0807.77
2021-0907.44
2021-10010.18
2021-11010.54
2021-1207.71
2022-0107.26
2022-0208.28
2022-03011.32
2022-04011.07
2022-05015.27
2022-06010.68
2022-0707.27
2022-0809.14
2022-09012.08
2022-10016.46
2022-1109.11
2022-12012.31
2023-01010.07
2023-02017.6
2023-03019.41
2023-04021.93
2023-05021.78
2023-06014.76
2023-07027.83
2023-08032.21
2023-09032.73
2023-10021.29
2023-11031.3
2023-12028.87
2024-01026.92
2024-02023.95
2024-03030.02
2024-04016.76
2024-05018.2
2024-06015.54
2024-07026.88
2024-08024.81
2024-09030.13
2024-10036.26
2024-11026.81
2024-12022.65
2025-01028.25
2025-02022
2025-03027.79
2025-04017.38
2025-05014.64
2025-06010.52
2025-07010.23
2025-0808.61
2025-0909.3
2025-10014.12
2025-1108.46
2025-12011.1
2026-01011.34
2026-02010.34
2026-03011.79
2026-04031.1
2026-05015.68
2026-06013.5
This device (reports/month)Average device in DQA (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K131971 — cited as predicate by K152552, K161056, K221879

K192514 — cites (transitively): K160981 (d1), K182075 (d1), K182821 (d1), K011291 (d2), K042346 (d2), K042536 (d2), K051212 (d2), K170712 (d2), K132038 (d3), K152902 (d3), K072235 (d4), K101521 (d4), K143195 (d4), K150352 (d4), K150632 (d4), K003621 (d5), K030738 (d5), K073376 (d5), K092449 (d5), K123074 (d5), K132026 (d5), K132037 (d5), K132075 (d5), K020550 (d5), K062098 (d5), K070791 (d5), K091834 (d5), K132036 (d5), K132662 (d5), K142601 (d5), K080192 (d6), K091786 (d6), K102562 (d6), K031760 (d6), K021778 (d7), K030038 (d7), K032858 (d7), K033444 (d7), K041235 (d7), K050762 (d7), K053522 (d7), K082633 (d7), K100939 (d7) — cited as predicate by K202336, K202892, K220308

K232962 — cites (transitively): K180380 (d1), K182075 (d1), K202336 (d1), K202892 (d1), K211475 (d1), K220308 (d1), K120727 (d2), K131818 (d2), K160981 (d2), K192514 (d2), K011291 (d2), K132037 (d2), K171751 (d2), K171888 (d2), K182821 (d2), K191769 (d2), K193391 (d2), K141542 (d2), K200015 (d2), K200594 (d2), K210906 (d2), K003313 (d3), K120144 (d3), K072235 (d3), K051352 (d3), K060576 (d3), K123581 (d3), K120907 (d3), K130411 (d3), K150620 (d3), K151071 (d3), K042346 (d3), K042536 (d3), K051212 (d3), K170712 (d3), K020550 (d3), K062098 (d3), K070791 (d3), K091834 (d3), K092449 (d3), K150352 (d3), K153448 (d3), K172226 (d3), K183238 (d3), K103142 (d3), K141518 (d3), K150272 (d3), K101449 (d3), K110622 (d3), K161531 (d3), K021778 (d4), K100939 (d4), K032858 (d4), K033444 (d4), K042845 (d4), K051106 (d4), K052801 (d4), K062283 (d4), K062392 (d4), K102835 (d4), K111637 (d4), K110361 (d4), K110742 (d4), K110978 (d4), K111594 (d4), K012891 (d4), K083325 (d4), K120773 (d4), K033048 (d4), K111933 (d4), K121806 (d4), K130320 (d4), K112368 (d4), K101521 (d4), K132026 (d4), K143195 (d4), K130740 (d4), K140430 (d4), K102426 (d4), K121914 (d4), K150310 (d4), K150975 (d4), K151681 (d4), K132038 (d4), K152902 (d4), K101600 (d4), K103646 (d4), K111905 (d4), K113125 (d4), K150632 (d4), K162607 (d4), K170876 (d4), K172482 (d4), K003621 (d5), K030738 (d5), K073376 (d5), K033715 (d5), K041741 (d5), K081937 (d5), K090360 (d5), K050230 (d5), K073203 (d5), K040357 (d5), K063725 (d5), K081793 (d5), K081574 (d5), K081828 (d5), K051076 (d5), K060559 (d5), K033474 (d5), K931787 (d5), K062177 (d5), K091265 (d5), K110168 (d5), K083517 (d5), K051896 (d5), K101995 (d5), K040259 (d5), K121912 (d5), K001775 (d5), K090556 (d5), K123074 (d5), K132075 (d5), K132036 (d5), K132662 (d5), K142601 (d5), K021788 (d5), K030038 (d5), K031481 (d5), K040304 (d5), K041235 (d5), K050141 (d5), K050762 (d5), K053522 (d5), K060221 (d5), K060541 (d5), K061052 (d5), K061610 (d5), K063315 (d5), K071426 (d5), K072020 (d5), K082633 (d5), K091927 (d5), K093268 (d5), K102562 (d5), K110474 (d5), K113441 (d5), K113657 (d5), K120366 (d5), K120657 (d5), K122439 (d5), K130849 (d5), K131872 (d5), K141015 (d5), K033513 (d6), K171426 (d6), K172020 (d6), K080238 (d6), K094012 (d6), K042007 (d6), K013199 (d6), K093260 (d6), K033296 (d6), K092838 (d6), K101896 (d6), K052961 (d6), K082583 (d6), K080192 (d6), K091786 (d6), K031760 (d6), K082268 (d7), K131861 (d7), K141077 (d7), K081888 (d7), K101923 (d7), P960025 (d7), K081917 (d8), K090993 (d8) — cited as predicate by K250179, K252250

K250179 — cites (transitively): K180380 (d1), K232962 (d1), K120727 (d2), K131818 (d2), K160981 (d2), K182075 (d2), K202336 (d2), K202892 (d2), K211475 (d2), K220308 (d2), K003313 (d3), K120144 (d3), K192514 (d3), K011291 (d3), K132037 (d3), K171751 (d3), K171888 (d3), K182821 (d3), K191769 (d3), K193391 (d3), K141542 (d3), K200015 (d3), K200594 (d3), K210906 (d3), K102835 (d4), K111637 (d4), K072235 (d4), K051352 (d4), K060576 (d4), K123581 (d4), K120907 (d4), K130411 (d4), K150620 (d4), K151071 (d4), K042346 (d4), K042536 (d4), K051212 (d4), K170712 (d4), K020550 (d4), K062098 (d4), K070791 (d4), K091834 (d4), K092449 (d4), K150352 (d4), K153448 (d4), K172226 (d4), K183238 (d4), K103142 (d4), K141518 (d4), K150272 (d4), K101449 (d4), K110622 (d4), K161531 (d4), K021778 (d5), K100939 (d5), K032858 (d5), K033444 (d5), K042845 (d5), K051106 (d5), K052801 (d5), K062283 (d5), K062392 (d5), K110361 (d5), K110742 (d5), K110978 (d5), K111594 (d5), K012891 (d5), K083325 (d5), K120773 (d5), K033048 (d5), K111933 (d5), K121806 (d5), K130320 (d5), K112368 (d5), K101521 (d5), K132026 (d5), K143195 (d5), K130740 (d5), K140430 (d5), K102426 (d5), K121914 (d5), K150310 (d5), K150975 (d5), K151681 (d5), K132038 (d5), K152902 (d5), K101600 (d5), K103646 (d5), K111905 (d5), K113125 (d5), K150632 (d5), K162607 (d5), K170876 (d5), K172482 (d5), K003621 (d6), K030738 (d6), K073376 (d6), K033715 (d6), K041741 (d6), K081937 (d6), K090360 (d6), K050230 (d6), K073203 (d6), K040357 (d6), K063725 (d6), K081793 (d6), K081574 (d6), K081828 (d6), K051076 (d6), K060559 (d6), K033474 (d6), K931787 (d6), K062177 (d6), K091265 (d6), K110168 (d6), K083517 (d6), K051896 (d6), K101995 (d6), K040259 (d6), K121912 (d6), K001775 (d6), K090556 (d6), K123074 (d6), K132075 (d6), K132036 (d6), K132662 (d6), K142601 (d6), K021788 (d6), K030038 (d6), K031481 (d6), K040304 (d6), K041235 (d6), K050141 (d6), K050762 (d6), K053522 (d6), K060221 (d6), K060541 (d6), K061052 (d6), K061610 (d6), K063315 (d6), K071426 (d6), K072020 (d6), K082633 (d6), K091927 (d6), K093268 (d6), K102562 (d6), K110474 (d6), K113441 (d6), K113657 (d6), K120366 (d6), K120657 (d6), K122439 (d6), K130849 (d6), K131872 (d6), K141015 (d6), K033513 (d7), K171426 (d7), K172020 (d7), K080238 (d7), K094012 (d7), K042007 (d7), K013199 (d7), K093260 (d7), K033296 (d7), K092838 (d7), K101896 (d7), K052961 (d7), K082583 (d7), K080192 (d7), K091786 (d7), K031760 (d7), K082268 (d8), K131861 (d8), K141077 (d8), K081888 (d8), K101923 (d8), P960025 (d8)

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

Manufacturer compliance record — Edan Instruments, Inc.

  • NAI 2012-11-29 Edan Instruments, Inc. · 0 citations
  • NAI 2012-11-29 Edan Instruments, Inc. · 0 citations