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INFINITY M300 Nellcor WPA2

Model MS26076 · DRAEGER MEDICAL SYSTEMS, INC. · DI 04049098002035

MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) · Class II · 21 CFR 870.1025

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (2)

InitiatedRecall #ClassStatusReasonLink basis
2022-03-04Z-1012-2022Class IIOpen, ClassifiedSoftware issue resulting in temporary loss of central monitoring functionality.k number procode
2019-10-09Z-0372-2020Class IIOpen, ClassifiedThe devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.k number procode

Adverse-event reports — MAUDE (4)

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.

Malfunction: 3 · Death: 1

61218242019-01: 0 reports for this device; peer average 8.07/device2019-02: 0 reports for this device; peer average 2.73/device2019-03: 0 reports for this device; peer average 4/device2019-04: 0 reports for this device; peer average 3.67/device2019-05: 0 reports for this device; peer average 5.74/device2019-06: 0 reports for this device; peer average 4.87/device2019-07: 0 reports for this device; peer average 7.26/device2019-08: 0 reports for this device; peer average 6.92/device2019-09: 0 reports for this device; peer average 6.77/device2019-10: 0 reports for this device; peer average 8.24/device2019-11: 0 reports for this device; peer average 9.4/device2019-12: 0 reports for this device; peer average 6.33/device2020-01: 0 reports for this device; peer average 5.84/device2020-02: 0 reports for this device; peer average 7.47/device2020-03: 0 reports for this device; peer average 5.73/device2020-04: 0 reports for this device; peer average 6.16/device2020-05: 0 reports for this device; peer average 4.85/device2020-06: 0 reports for this device; peer average 6.05/device2020-07: 0 reports for this device; peer average 7.95/device2020-08: 0 reports for this device; peer average 6.22/device2020-09: 0 reports for this device; peer average 7.08/device2020-10: 0 reports for this device; peer average 5.39/device2020-11: 0 reports for this device; peer average 9.22/device2020-12: 0 reports for this device; peer average 9.6/device2021-01: 0 reports for this device; peer average 6.13/device2021-02: 0 reports for this device; peer average 10.29/device2021-03: 0 reports for this device; peer average 14.31/device2021-04: 0 reports for this device; peer average 18.59/device2021-05: 0 reports for this device; peer average 11.03/device2021-06: 0 reports for this device; peer average 12.86/device2021-07: 0 reports for this device; peer average 15.92/device2021-08: 0 reports for this device; peer average 18.12/device2021-09: 0 reports for this device; peer average 12.52/device2021-10: 0 reports for this device; peer average 12.73/device2021-11: 0 reports for this device; peer average 11.77/device2021-12: 0 reports for this device; peer average 13.28/device2022-01: 0 reports for this device; peer average 8.79/device2022-02: 0 reports for this device; peer average 9.71/device2022-03: 0 reports for this device; peer average 9.32/device2022-04: 0 reports for this device; peer average 7.18/device2022-05: 0 reports for this device; peer average 9.26/device2022-06: 0 reports for this device; peer average 5/device2022-07: 0 reports for this device; peer average 8.5/device2022-08: 0 reports for this device; peer average 8.4/device2022-09: 0 reports for this device; peer average 4.08/device2022-10: 0 reports for this device; peer average 4.85/device2022-11: 0 reports for this device; peer average 6.86/device2022-12: 0 reports for this device; peer average 6.34/device2023-01: 0 reports for this device; peer average 6.31/device2023-02: 0 reports for this device; peer average 7.55/device2023-03: 0 reports for this device; peer average 16.15/device2023-04: 0 reports for this device; peer average 11.67/device2023-05: 0 reports for this device; peer average 11.62/device2023-06: 0 reports for this device; peer average 10.37/device2023-07: 1 reports for this device; peer average 9.83/device2023-08: 0 reports for this device; peer average 9.53/device2023-09: 0 reports for this device; peer average 14.33/device2023-10: 0 reports for this device; peer average 10.53/device2023-11: 0 reports for this device; peer average 7.92/device2023-12: 0 reports for this device; peer average 12.07/device2024-01: 0 reports for this device; peer average 8.63/device2024-02: 0 reports for this device; peer average 11.08/device2024-03: 0 reports for this device; peer average 12.58/device2024-04: 0 reports for this device; peer average 9.02/device2024-05: 1 reports for this device; peer average 10.2/device2024-06: 0 reports for this device; peer average 9.88/device2024-07: 0 reports for this device; peer average 8.36/device2024-08: 0 reports for this device; peer average 11.2/device2024-09: 0 reports for this device; peer average 9.38/device2024-10: 1 reports for this device; peer average 12.55/device2024-11: 0 reports for this device; peer average 11.68/device2024-12: 0 reports for this device; peer average 10.27/device2025-01: 0 reports for this device; peer average 12.54/device2025-02: 0 reports for this device; peer average 11.46/device2025-03: 0 reports for this device; peer average 16.37/device2025-04: 0 reports for this device; peer average 13/device2025-05: 0 reports for this device; peer average 13.62/device2025-06: 0 reports for this device; peer average 16.23/device2025-07: 0 reports for this device; peer average 18.92/device2025-08: 0 reports for this device; peer average 13.56/device2025-09: 0 reports for this device; peer average 13.69/device2025-10: 0 reports for this device; peer average 22.11/device2025-11: 1 reports for this device; peer average 15.64/device2025-12: 0 reports for this device; peer average 18.23/device2026-01: 0 reports for this device; peer average 17.16/device2026-02: 0 reports for this device; peer average 22.52/device2026-03: 0 reports for this device; peer average 22.05/device2026-04: 0 reports for this device; peer average 19.73/device2026-05: 0 reports for this device; peer average 23.7/device2026-06: 0 reports for this device; peer average 21.32/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0108.07
2019-0202.73
2019-0304
2019-0403.67
2019-0505.74
2019-0604.87
2019-0707.26
2019-0806.92
2019-0906.77
2019-1008.24
2019-1109.4
2019-1206.33
2020-0105.84
2020-0207.47
2020-0305.73
2020-0406.16
2020-0504.85
2020-0606.05
2020-0707.95
2020-0806.22
2020-0907.08
2020-1005.39
2020-1109.22
2020-1209.6
2021-0106.13
2021-02010.29
2021-03014.31
2021-04018.59
2021-05011.03
2021-06012.86
2021-07015.92
2021-08018.12
2021-09012.52
2021-10012.73
2021-11011.77
2021-12013.28
2022-0108.79
2022-0209.71
2022-0309.32
2022-0407.18
2022-0509.26
2022-0605
2022-0708.5
2022-0808.4
2022-0904.08
2022-1004.85
2022-1106.86
2022-1206.34
2023-0106.31
2023-0207.55
2023-03016.15
2023-04011.67
2023-05011.62
2023-06010.37
2023-0719.83
2023-0809.53
2023-09014.33
2023-10010.53
2023-1107.92
2023-12012.07
2024-0108.63
2024-02011.08
2024-03012.58
2024-0409.02
2024-05110.2
2024-0609.88
2024-0708.36
2024-08011.2
2024-0909.38
2024-10112.55
2024-11011.68
2024-12010.27
2025-01012.54
2025-02011.46
2025-03016.37
2025-04013
2025-05013.62
2025-06016.23
2025-07018.92
2025-08013.56
2025-09013.69
2025-10022.11
2025-11115.64
2025-12018.23
2026-01017.16
2026-02022.52
2026-03022.05
2026-04019.73
2026-05023.7
2026-06021.32
This device (reports/month)Average device in MHX (reports/device/month)

Regulatory clearances

  • K130711 SESE 2013-04-11 (k number procode)

Predicate lineage

K130711 — cites (transitively): K061379 (d1) — cited as predicate by K151860, K200859

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

Manufacturer compliance record — DRAEGER MEDICAL SYSTEMS, INC.

  • Warning Letter 2020-01-17 Draeger Medical Systems, Inc.
  • Warning Letter 2020-01-17 Draeger Medical Systems, Inc.
  • NAI 2024-11-27 Draeger Medical Systems, Inc. · 0 citations
  • NAI 2024-11-27 Draeger Medical Systems, Inc. · 0 citations
  • NAI 2022-08-15 Draeger Medical Systems, Inc. · 0 citations
  • NAI 2022-08-15 Draeger Medical Systems, Inc. · 0 citations
  • VAI 2022-04-21 Draeger Medical Systems, Inc. · 2 citations
  • VAI 2022-04-21 Draeger Medical Systems, Inc. · 2 citations
  • OAI 2019-09-20 Draeger Medical Systems, Inc. · 0 citations
  • OAI 2019-09-20 Draeger Medical Systems, Inc. · 0 citations
  • VAI 2013-07-03 Draeger Medical Systems, Inc. · 1 citations
  • VAI 2013-07-03 Draeger Medical Systems, Inc. · 1 citations
  • VAI 2013-04-12 Draeger Medical Systems, Inc. · 0 citations
  • VAI 2013-04-12 Draeger Medical Systems, Inc. · 0 citations