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Stroller 10564125

by Caire Inc.

Stroller 10564125 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 17 Aug 2016 (UDI-DI M766105641250), 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 NumberM766105641250 UDI-DI Date17 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 M766105641250 listed 17 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 M766105641250
  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  • Withdrawn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
Stroller
Generic name
Portable liquid oxygen unit
Model / reference
10564125
Description
Portable Liquid Oxygen Respiratory Equipment, Side Fill, 6 LPM, 20 PSI
Primary DI / UDI-DI
M766105641250
510(k) Number
FDA product code
BYJ
GMDN term
Portable liquid oxygen unit
Device class
Class II
Regulation number
868.5655
GUDID distribution status
In Commercial Distribution

Related devices

Category: Portable liquid oxygen unit

Cleared under the same submission (K800742)

and 8 more cleared under K800742

Similar devices

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

Other devices from Caire Inc.

See all devices from Caire Inc. →

Properties

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