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Nellcor

Model MAXA-NS · Covidien LP · DI 10884522040068

DQA — Oximeter · Class II · 21 CFR 870.2700

UDILibrary device dossier · generated 2026-09-14 · 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

K012891 — cited as predicate by K123581, K130320, K150329, K162014, K180734, K181738, K190468, K192404, K201179, K211138, K212555, K250854, K253109

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

Manufacturer compliance record — Covidien LP

  • Warning Letter 2012-06-14 Covidien, LP
  • Warning Letter 2012-06-14 Covidien, LP
  • Warning Letter 2011-10-04 Oridion Medical 1987 Ltd.
  • NAI 2025-07-16 Covidien LLC · 0 citations
  • NAI 2025-07-16 Covidien LLC · 0 citations
  • NAI 2024-11-21 Covidien, LP · 0 citations
  • NAI 2024-11-21 Covidien, LP · 0 citations
  • VAI 2022-11-18 Covidien LP · 1 citations
  • VAI 2022-11-18 Covidien LP · 1 citations
  • VAI 2022-09-08 Covidien · 0 citations
  • VAI 2022-09-08 Covidien · 0 citations
  • OAI 2022-04-28 Covidien · 2 citations
  • OAI 2022-04-28 Covidien · 2 citations
  • VAI 2020-02-28 Covidien, LP · 1 citations
  • VAI 2020-02-28 Covidien, LP · 1 citations
  • NAI 2018-09-19 Covidien · 0 citations
  • NAI 2018-09-19 Covidien · 0 citations
  • VAI 2017-09-22 Covidien, LLC · 2 citations
  • VAI 2017-09-22 Covidien, LLC · 2 citations
  • NAI 2017-08-09 Covidien · 0 citations
  • NAI 2017-08-09 Covidien · 0 citations
  • NAI 2016-10-31 Covidien · 0 citations
  • NAI 2016-10-31 Covidien · 0 citations