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731 ventilator

Model 8660-001403-01-66 · Zoll Medical Corporation · DI 00812394023370

CBK — Ventilator, Continuous, Facility Use · Class II · 21 CFR 868.5895

DQA — Oximeter · Class II · 21 CFR 870.2700

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.

91828372019-01: 0 reports for this device; peer average 9.76/device2019-02: 0 reports for this device; peer average 10.3/device2019-03: 0 reports for this device; peer average 8.16/device2019-04: 0 reports for this device; peer average 8.99/device2019-05: 0 reports for this device; peer average 7.43/device2019-06: 0 reports for this device; peer average 9/device2019-07: 0 reports for this device; peer average 9.05/device2019-08: 0 reports for this device; peer average 9.9/device2019-09: 0 reports for this device; peer average 10.42/device2019-10: 0 reports for this device; peer average 8.33/device2019-11: 0 reports for this device; peer average 8.4/device2019-12: 0 reports for this device; peer average 9.34/device2020-01: 0 reports for this device; peer average 8.69/device2020-02: 0 reports for this device; peer average 8.63/device2020-03: 0 reports for this device; peer average 8.44/device2020-04: 0 reports for this device; peer average 11.9/device2020-05: 0 reports for this device; peer average 8.65/device2020-06: 0 reports for this device; peer average 8.23/device2020-07: 0 reports for this device; peer average 8.3/device2020-08: 0 reports for this device; peer average 8.68/device2020-09: 0 reports for this device; peer average 9.38/device2020-10: 0 reports for this device; peer average 10.65/device2020-11: 0 reports for this device; peer average 10.5/device2020-12: 0 reports for this device; peer average 11.17/device2021-01: 0 reports for this device; peer average 10.13/device2021-02: 0 reports for this device; peer average 10.49/device2021-03: 0 reports for this device; peer average 13.14/device2021-04: 0 reports for this device; peer average 9.98/device2021-05: 0 reports for this device; peer average 8.85/device2021-06: 0 reports for this device; peer average 11.11/device2021-07: 0 reports for this device; peer average 9.25/device2021-08: 0 reports for this device; peer average 10.65/device2021-09: 0 reports for this device; peer average 9.95/device2021-10: 0 reports for this device; peer average 11.56/device2021-11: 0 reports for this device; peer average 11.5/device2021-12: 0 reports for this device; peer average 10.03/device2022-01: 0 reports for this device; peer average 8.62/device2022-02: 0 reports for this device; peer average 10.69/device2022-03: 0 reports for this device; peer average 14.95/device2022-04: 0 reports for this device; peer average 11.52/device2022-05: 0 reports for this device; peer average 13.82/device2022-06: 0 reports for this device; peer average 12.9/device2022-07: 0 reports for this device; peer average 8.84/device2022-08: 0 reports for this device; peer average 10.56/device2022-09: 0 reports for this device; peer average 12.9/device2022-10: 0 reports for this device; peer average 16.11/device2022-11: 0 reports for this device; peer average 12.38/device2022-12: 0 reports for this device; peer average 15.64/device2023-01: 0 reports for this device; peer average 12.95/device2023-02: 0 reports for this device; peer average 18.65/device2023-03: 0 reports for this device; peer average 22.54/device2023-04: 0 reports for this device; peer average 22.45/device2023-05: 0 reports for this device; peer average 22.01/device2023-06: 0 reports for this device; peer average 18.8/device2023-07: 0 reports for this device; peer average 25.66/device2023-08: 0 reports for this device; peer average 31.51/device2023-09: 0 reports for this device; peer average 30.8/device2023-10: 0 reports for this device; peer average 25.75/device2023-11: 0 reports for this device; peer average 33.15/device2023-12: 0 reports for this device; peer average 29.43/device2024-01: 0 reports for this device; peer average 25.89/device2024-02: 0 reports for this device; peer average 23.77/device2024-03: 0 reports for this device; peer average 28.7/device2024-04: 0 reports for this device; peer average 19.15/device2024-05: 0 reports for this device; peer average 20.59/device2024-06: 0 reports for this device; peer average 18.53/device2024-07: 0 reports for this device; peer average 26.29/device2024-08: 0 reports for this device; peer average 25.62/device2024-09: 0 reports for this device; peer average 30.09/device2024-10: 0 reports for this device; peer average 36.93/device2024-11: 0 reports for this device; peer average 30.57/device2024-12: 0 reports for this device; peer average 26.79/device2025-01: 0 reports for this device; peer average 30.54/device2025-02: 0 reports for this device; peer average 25.15/device2025-03: 0 reports for this device; peer average 30.03/device2025-04: 0 reports for this device; peer average 24.65/device2025-05: 0 reports for this device; peer average 23.61/device2025-06: 0 reports for this device; peer average 20.74/device2025-07: 0 reports for this device; peer average 19/device2025-08: 0 reports for this device; peer average 16.87/device2025-09: 0 reports for this device; peer average 18.14/device2025-10: 0 reports for this device; peer average 19.97/device2025-11: 0 reports for this device; peer average 18.56/device2025-12: 0 reports for this device; peer average 21.67/device2026-01: 0 reports for this device; peer average 18.13/device2026-02: 0 reports for this device; peer average 18.28/device2026-03: 0 reports for this device; peer average 22.6/device2026-04: 0 reports for this device; peer average 36.99/device2026-05: 0 reports for this device; peer average 20.93/device2026-06: 0 reports for this device; peer average 21.56/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0109.76
2019-02010.3
2019-0308.16
2019-0408.99
2019-0507.43
2019-0609
2019-0709.05
2019-0809.9
2019-09010.42
2019-1008.33
2019-1108.4
2019-1209.34
2020-0108.69
2020-0208.63
2020-0308.44
2020-04011.9
2020-0508.65
2020-0608.23
2020-0708.3
2020-0808.68
2020-0909.38
2020-10010.65
2020-11010.5
2020-12011.17
2021-01010.13
2021-02010.49
2021-03013.14
2021-0409.98
2021-0508.85
2021-06011.11
2021-0709.25
2021-08010.65
2021-0909.95
2021-10011.56
2021-11011.5
2021-12010.03
2022-0108.62
2022-02010.69
2022-03014.95
2022-04011.52
2022-05013.82
2022-06012.9
2022-0708.84
2022-08010.56
2022-09012.9
2022-10016.11
2022-11012.38
2022-12015.64
2023-01012.95
2023-02018.65
2023-03022.54
2023-04022.45
2023-05022.01
2023-06018.8
2023-07025.66
2023-08031.51
2023-09030.8
2023-10025.75
2023-11033.15
2023-12029.43
2024-01025.89
2024-02023.77
2024-03028.7
2024-04019.15
2024-05020.59
2024-06018.53
2024-07026.29
2024-08025.62
2024-09030.09
2024-10036.93
2024-11030.57
2024-12026.79
2025-01030.54
2025-02025.15
2025-03030.03
2025-04024.65
2025-05023.61
2025-06020.74
2025-07019
2025-08016.87
2025-09018.14
2025-10019.97
2025-11018.56
2025-12021.67
2026-01018.13
2026-02018.28
2026-03022.6
2026-04036.99
2026-05020.93
2026-06021.56
This device (reports/month)Average device in CBK, DQA (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Zoll Medical Corporation

  • Warning Letter 2026-04-30 ZOLL Medical Corporation
  • Warning Letter 2026-04-30 ZOLL Medical Corporation
  • Warning Letter 2011-04-22 ZOLL Medical Corporation
  • Warning Letter 2011-04-22 ZOLL Medical Corporation
  • Warning Letter 2010-09-30 ZOLL Medical Corporation
  • Warning Letter 2010-09-30 ZOLL Medical Corporation
  • Warning Letter 2010-02-05 Zoll Medical Corporation
  • Warning Letter 2010-02-05 Zoll Medical Corporation
  • VAI 2025-07-24 ZOLL Medical Corporation · 0 citations
  • VAI 2025-07-24 ZOLL Medical Corporation · 0 citations
  • OAI 2025-04-15 ZOLL Medical Corporation · 5 citations
  • OAI 2025-04-15 ZOLL Medical Corporation · 5 citations
  • VAI 2024-02-13 ZOLL Circulation, Inc. · 0 citations
  • VAI 2024-02-13 ZOLL Circulation, Inc. · 0 citations
  • VAI 2022-06-13 Zoll Medical Corporation · 5 citations
  • VAI 2022-06-13 Zoll Medical Corporation · 5 citations
  • NAI 2022-04-08 Vyaire Medical, Inc. · 0 citations
  • VAI 2022-03-10 ZOLL Medical Corporation · 4 citations
  • VAI 2022-03-10 ZOLL Medical Corporation · 4 citations
  • VAI 2017-11-09 ZOLL Circulation, Inc. · 3 citations
  • VAI 2017-10-25 ZOLL Medical Corporation · 5 citations
  • VAI 2017-10-25 ZOLL Medical Corporation · 5 citations
  • NAI 2017-05-05 Vyaire Medical, Inc. · 0 citations
  • VAI 2016-10-18 ZOLL Medical Corporation · 0 citations
  • VAI 2016-10-18 ZOLL Medical Corporation · 0 citations
  • NAI 2016-08-26 ZOLL Medical Corporation · 0 citations
  • NAI 2016-08-26 ZOLL Medical Corporation · 0 citations
  • NAI 2016-04-08 ZOLL Medical Corporation · 0 citations