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FDA 510(k)

The BAG manual resuscitator and accessories

K-Number: K251631 · 2025-11-24

ApplicantLaerdal Medical AS
Decision Date2025-11-24
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

The BAG manual resuscitator and accessories is a medical device manufactured by Laerdal Medical AS. It received FDA 510(k) clearance on 2025-11-24 under approval number K251631. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The BAG manual resuscitator and accessories?

The BAG manual resuscitator and accessories is a medical device that received FDA 510(k) clearance on 2025-11-24. It is manufactured by Laerdal Medical AS. The 510(k) number is K251631.

When was The BAG manual resuscitator and accessories approved by the FDA?

The BAG manual resuscitator and accessories received FDA 510(k) clearance on 2025-11-24, under approval number K251631.

What company makes The BAG manual resuscitator and accessories?

The BAG manual resuscitator and accessories is manufactured by Laerdal Medical AS.

What is the FDA product code for The BAG manual resuscitator and accessories?

The FDA product code for The BAG manual resuscitator and accessories is BTM.

Related Clinical Trials

NCT06849596 Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates RECRUITING

Other Devices by Laerdal Medical AS

K183348Reusable Silicone Cover CPRmeter 2 K173886CPRmeter 2 CPR Feedback Device K232111NeoBeat, NeoBeat Mini

Related Devices (Code: BTM)

K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant ResuscitatorAmbu A/S K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20Flexicare Medical Limited. K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable ManometerForemount Enterprise Co., Ltd. K210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd. K212905Sotair DeviceSafe Bvm Corporation K221841EOlife®Archeon

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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