Spur Infant/Child W/O Pressure-Limiting Valve

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K923762 ↗

FDA Product Code

BTM

Device Class

Class II

Regulation

21 CFR Part 868.5915

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Ambu Neuroline Ground

  Class II

  FDA 510(k) K051529 Active Cleared 4 Aug 2005

• Ambu Medibag Adult, Ambu Medibag Infant/Child

  Class II

  FDA 510(k) K982722 Active Cleared 12 Apr 1999

• Ambu Silicone Resuscitator, Adult W/Open Reservoir

  Class II

  FDA 510(k) K924215 Active Cleared 16 Sep 1992

• Ambu Hand Power Suction Pump

  Class I

  FDA 510(k) K992902 Active Cleared 25 Oct 1999

• Ambu Spur Neonate

  Class II

  FDA 510(k) K964584 Active Cleared 15 May 1997

• Ambu Disposable ECG Electrode

  Class II

  FDA 510(k) K041734 Active Cleared 22 Sep 2004

See all devices from Ambu, Inc. →

• What is the primary use of this device?

  This device is a manual resuscitator, classified as an emergency ventilator, intended to provide respiratory support specifically for infant and child patients.

• Is this device intended for multiple uses?

  No, the device is intended for single-patient use only to ensure patient safety and prevent cross-contamination.

• What is the regulatory status of this resuscitator?

  This device is authorized under FDA 510K clearance, which indicates that it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.