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Ambu Spur II Adult Single Patient Resuscitator

by Ambu, Inc.

510(k) K042682

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042682 Date15 Nov 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ambu Spur II Adult Single Patient Resuscitator is a manual emergency resuscitator classified as a ventilator, emergency, manual (resuscitator). It is intended for single‑patient use in adult patients to provide manual ventilation during resuscitation efforts.

The device is supplied as a disposable, single‑use unit and was cleared through the FDA 510(k) pathway (traditional clearance, decision date 2004‑11‑15). It is a Class II device (product code BTM) and is marketed for use in hospital and emergency settings.

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