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Inspira Air BC0524A

by Acclarent, Inc.

Inspira Air BC0524A is a Class II device made by Acclarent, Inc., cleared under FDA 510(k) K090660 on 12 Jun 2009 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 10705031131996), active as of 23 Oct 2026. 7 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 closed

Documents

510(k) K090660

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705031131996 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK090660 Date12 Jun 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090660 decided 12 Jun 2009 Active
  • FDA GUDID UDI-DI 10705031131996 listed 1 Sep 2016 Listed

Recalls

7 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-1863-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-1862-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-1866-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-1864-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-1860-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-1865-2013 FDA Class II initiated 11 Jan 2013
    • Terminated Z-1861-2013 FDA Class II initiated 11 Jan 2013

    Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.

Timeline

9 dated events

  1. Cleared FDA 510(k) K090660
  2. Recall initiated FDA recalls Z-1863-2013
  3. Recall initiated FDA recalls Z-1862-2013
  4. Recall initiated FDA recalls Z-1866-2013
  5. Recall initiated FDA recalls Z-1864-2013
  6. Recall initiated FDA recalls Z-1860-2013
  7. Recall initiated FDA recalls Z-1865-2013
  8. Recall initiated FDA recalls Z-1861-2013
  9. Listed FDA GUDID 10705031131996

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Inspira Air
Generic name
Bronchial balloon catheter
Model / Ref / Catalog
BC0524A
Primary DI / UDI-DI
10705031131996
FDA product code
KTI
GMDN term
Bronchial balloon catheter
Device class
Class II
Regulation number
874.4680
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bronchial balloon catheter

Cleared under the same submission (K090660)

and 7 more cleared under K090660

Similar devices

Other devices filed under FDA product code KTI (BRONCHOSCOPE ACCESSORY).

Other devices from Acclarent, Inc.

See all devices from Acclarent, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)