Skip to content

Bipap Synchrony 2 Ventilatory Support System

by Respironics Inc., Sleep & Home Respiratory Group

510(k) K071509

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 · Special NumberK071509 Date8 Aug 2007ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1061-2008 FDA Unclassified (pre-2012) initiated 15 Oct 2007
    • Terminated Z-1088-2008 FDA Unclassified (pre-2012) initiated 15 Oct 2007

    Foreign material: Glass fragments may present in the plastic bag material used to ship components.

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  • Withdrawn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

Other devices from Respironics Inc., Sleep & Home Respiratory Group

See all devices from Respironics Inc., Sleep & Home Respiratory Group →