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Liberator 13259548

by Caire Inc.

Liberator 13259548 is a Class II device made by Caire Inc., cleared under FDA 510(k) K800742 on 23 May 1980 and listed in FDA GUDID since 25 Aug 2016 (UDI-DI M766132595480), active as of 23 Oct 2026. 4 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

4 closed

Documents

510(k) K800742

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 NumberM766132595480 UDI-DI Date25 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK800742 Date23 May 1980DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K800742 decided 23 May 1980 Active
  • FDA GUDID UDI-DI M766132595480 listed 25 Aug 2016 Listed

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0337-2023 FDA Class I initiated 10 Oct 2022
    • Terminated Z-0338-2023 FDA Class I initiated 10 Oct 2022
    • Terminated Z-0339-2023 FDA Class I initiated 10 Oct 2022
    • Terminated Z-0336-2023 FDA Class I initiated 10 Oct 2022

    An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.

Timeline

6 dated events

  1. Cleared FDA 510(k) K800742
  2. Listed FDA GUDID M766132595480
  3. Recall initiated FDA recalls Z-0337-2023
  4. Recall initiated FDA recalls Z-0338-2023
  5. Recall initiated FDA recalls Z-0339-2023
  6. Recall initiated FDA recalls Z-0336-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Liberator
Generic name
Stationary liquid oxygen container
Model / reference
13259548
Primary DI / UDI-DI
M766132595480
510(k) Number
FDA product code
BYJ
GMDN term
Stationary liquid oxygen container
Device class
Class II
Regulation number
868.5655
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stationary liquid oxygen container

Cleared under the same submission (K800742)

and 8 more cleared under K800742

Similar devices

Also classified as Stationary liquid oxygen container.

Similar devices

Other devices filed under FDA product code BYJ (Unit, Liquid-Oxygen, Portable).

Other devices from Caire Inc.

  • Spirit

    Class IIa

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    Class II

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    Class II

  • Stroller 14770508

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See all devices from Caire Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)