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Ambu Spur (Single Patient Use Resuscitator) Infant

by Ambu, Inc. 510(k)

Active United States

510(k) K902261

Overview

The Ambu Spur (Single Patient Use Resuscitator) Infant is a manual ventilator device designed for emergency resuscitation. It is classified as a Ventilator, Emergency, Manual (Resuscitator) under FDA device classification.

This device is intended for single patient use and is supplied as a non-sterile, disposable resuscitator for infant patients. It has received FDA 510(k) clearance under K902261 with product code BTM and regulation number 868.5915, and is manufactured by Ambu, Inc. in Hanover, MD.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK902261 Date16 Jul 1990ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
BTM
Device Class
Class II
Regulation
21 CFR Part 868.5915
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Ambu Spur Infant Resuscitator used for?

    The Ambu Spur Infant Resuscitator is designed for emergency resuscitation of infant patients, providing manual ventilation in critical situations where immediate respiratory support is needed.

  • Is the Ambu Spur Infant Resuscitator sterile or non-sterile when supplied?

    The device is supplied as non-sterile and disposable, intended for single patient use only, which means it should be discarded after one use to prevent cross-contamination.

  • What regulatory pathway was used for the Ambu Spur Infant Resuscitator?

    The device received FDA 510(k) clearance under submission number K902261, demonstrating substantial equivalence to a legally marketed predicate device.

  • Who manufactures the Ambu Spur Infant Resuscitator and where is it made?

    The Ambu Spur Infant Resuscitator is manufactured by Ambu, Inc. at their facility located in Hanover, Maryland, United States.