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Liberator/Stroller II System

by Cryogenic Assoc. 510(k)

Active United States

510(k) K800742

Overview

The Liberator/Stroller II System is a portable, liquid-oxygen unit classified under FDA device class 2 with product code BYJ. It is designated for use in the medical specialty of anesthesiology.

The system was submitted as a traditional 510(k) premarket notification by Cryogenic Assoc., received on April 3, 1980, and found substantially equivalent on May 23, 1980, under regulation number 868.5655. It is supplied as a non-sterile, reusable device intended for use in clinical settings requiring portable liquid-oxygen delivery.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK800742 Date23 May 1980ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

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.

Specification

510(k)

510(k) Number
FDA Product Code
BYJ
Device Class
Class II
Regulation
21 CFR Part 868.5655
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Cryogenic Assoc.

Questions

  • What is the Liberator/Stroller II System used for?

    The Liberator/Stroller II System is designated for use in the medical specialty of anesthesiology, providing portable liquid-oxygen delivery in clinical settings.

  • Is the Liberator/Stroller II System sterile or non-sterile, and is it intended for single use or reuse?

    The system is supplied as a non-sterile, reusable device, meaning it is not provided in a sterile condition and is designed for multiple uses after appropriate cleaning and reprocessing.

  • What regulatory pathway was used for the Liberator/Stroller II System, and when was it cleared?

    The Liberator/Stroller II System was submitted as a traditional 510(k) premarket notification, received on April 3, 1980, and found substantially equivalent on May 23, 1980, under regulation 868.5655.