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AirLife™

Model SFT2601 · VYAIRE MEDICAL, INC. · DI 10190752117730

NFB — Conserver, Oxygen · Class II · 21 CFR 868.5905

UDILibrary device dossier · generated 2026-09-06 · 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 (9)

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: 5 · Injury: 4

12232020-12: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 3/device2023-08: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2/device2025-10: 2 reports for this device; peer average 2/device2025-11: 3 reports for this device; peer average 3/device2025-12: 2 reports for this device; peer average 2/device2026-01: 2 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 2/device12080902030802071011120102
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-1201
2021-0801
2022-0902
2023-0201
2023-0303
2023-0802
2024-0202
2025-0702
2025-1022
2025-1133
2025-1222
2026-0122
2026-0202
This device (reports/month)Average device in NFB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — VYAIRE MEDICAL, INC.

  • NAI 2022-04-08 Vyaire Medical, Inc. · 0 citations
  • NAI 2017-05-05 Vyaire Medical, Inc. · 0 citations
  • NAI 2016-05-11 Vyaire Medical, Inc. · 0 citations
  • VAI 2014-10-31 Vyaire Medical, Inc. · 4 citations
  • NAI 2014-10-08 Vyaire Medical Inc · 0 citations
  • NAI 2014-09-30 Vyaire Medical · 0 citations
  • VAI 2012-09-05 Vyaire Medical · 5 citations
  • NAI 2012-01-10 Vyaire Medical · 0 citations
  • NAI 2012-01-10 Vyaire Medical · 0 citations
  • NAI 2011-11-25 Vyaire Medical · 0 citations
  • NAI 2011-08-22 Vyaire Medical, Inc. · 0 citations