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Bipap Focus

by Respironics (Ireland) Limited

510(k) K053168

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Traditional NumberK053168 Date4 Jan 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1606-2009 FDA Unclassified (pre-2012) initiated 22 Sep 2008

    Power Supply failures have occurred on some ventilators. A discrepancy between the power supply strain relief clip and the power cord connector may allow unwanted movement of the cord and the unit's power supply. A disconnection or intermittent electrical connection between the power cord and the unit's power supply during operation or charging can result in transient power surges, which may cau

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  • Withdrawn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