Skip to content

Aerosure 3481AJ

by Actegy, Ltd.

Aerosure 3481AJ (1474) is a Class II device made by Actegy, Ltd., cleared under FDA 510(k) K140772 on 19 Dec 2014 and listed in FDA GUDID since 4 May 2021 (UDI-DI 00858058005047), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K140772

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00858058005047 UDI-DI Date4 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK140772 Date19 Dec 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140772 decided 19 Dec 2014 Active
  • FDA GUDID UDI-DI 00858058005047 listed 4 May 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K140772
  2. Listed FDA GUDID 00858058005047

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aerosure
Generic name
Respiratory muscle training mask
Model / Ref / Catalog
3481AJ, 1474
Primary DI / UDI-DI
00858058005047
510(k) Number
FDA product code
BWF
GMDN term
Respiratory muscle training mask
Device class
Class II
Regulation number
868.5690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Respiratory muscle training mask

Similar devices

Other devices filed under FDA product code BWF (Spirometer, Therapeutic (Incentive)).

Other devices from Actegy, Ltd.

See all devices from Actegy, Ltd. →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)