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AirLife™ AH290

by Airlife, Inc. 2 variants

AirLife™ AH290 is a Class II device made by Airlife, Inc., cleared under FDA 510(k) K031745 on 13 Feb 2004 and listed in FDA GUDID since 12 Mar 2021 (UDI-DI 10190752144446), active as of 23 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 23 Oct 2026

Documents

510(k) K031745

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 Number10190752144446 UDI-DI Date12 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK031745 Date13 Feb 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K031745 decided 13 Feb 2004 Active
  • FDA GUDID UDI-DI 10190752144446 listed 12 Mar 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K031745
  2. Listed FDA GUDID 10190752144446

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AirLife™
Generic name
Inspiratory line humidification chamber, single-use
Model / Ref / Catalog
AH290
Primary DI / UDI-DI
10190752144446
510(k) Number
FDA product code
BZD
GMDN term
Inspiratory line humidification chamber, single-use
Device class
Class II
Regulation number
868.5905
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Inspiratory line humidification chamber, single-use.

Other devices from Airlife, Inc.

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Properties

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