Oxygen Concentrator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K924100 ↗

FDA Product Code

CAW

Device Class

Class II

Regulation

21 CFR Part 868.5440

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Schuco Mist and Schuco Deluxe Mist

  Class II

  FDA 510(k) K051260 Active Cleared 15 Sep 2005

• Mass Spectrometer-Medspect II

  Class I

  FDA 510(k) K810938 Active Cleared 23 Apr 1981

• Gomco Suction Pump Cabinet Change

  Class II

  FDA 510(k) K810490 Active Cleared 13 Mar 1981

• Bear Cub Infant Pressure Ventilator

  Class II

  FDA 510(k) K955865 Active Cleared 6 Aug 1996

• Ahp 300, Emergency Portable Ventilator

  Class II

  FDA 510(k) K132021 Active Cleared 2 Apr 2014

• Babybird Ventilator, Portable Lifecare Ventilator, External Pressure Limiter, Volume Ventilator with Pressure Limit

  Class II

  FDA 510(k) K972203 Active Cleared 6 Nov 1997

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