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Sprint 20597577

by Caire Inc.

Sprint 20597577 is a Class II device made by Caire Inc., cleared under FDA 510(k) K800742 on 23 May 1980, registered in EUDAMED and listed in FDA GUDID since 18 Aug 2016 (UDI-DI M766205975770), active as of 23 Oct 2026. 4 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

4 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K800742

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberM766205975770 UDI-DI Date18 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK800742 Date23 May 1980DecidedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K800742 decided 23 May 1980 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI M766205975770 listed 18 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 M766205975770
  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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Sprint
Generic name
Portable liquid oxygen unit
Model / reference
20597577
Primary DI / UDI-DI
M766205975770
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.

  • Spirit

    Class IIa

  • Stroller 10998054

    Class II

  • Stroller 10564125

    Class II

  • Stroller 14770508

    Class II

See all devices from Caire Inc. →

Properties

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