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Bipap Autosv

by Respironics Inc., Sleep & Home Respiratory Group

510(k) K090248

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK090248 Date4 Mar 2009ClearedStatusActive

Recalls

4 recalls · 4 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1659-2022 FDA Class I initiated 26 Aug 2022
    • Ongoing Z-1657-2022 FDA Class I initiated 26 Aug 2022
    • Ongoing Z-1655-2022 FDA Class I initiated 26 Aug 2022

    Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

    • Ongoing Z-1973-2021 FDA Class I initiated 14 Jun 2021

    The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MNS
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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