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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 the device name listed in this FDA 510(k) record. The listed applicant is Laerdal Medical AS. It received FDA 510(k) clearance on 2025-11-24 under 510(k) 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. The listed applicant is Laerdal Medical AS. The 510(k) number is K251631.

When did The BAG manual resuscitator and accessories receive FDA 510(k) clearance?

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

Who is the listed applicant for The BAG manual resuscitator and accessories?

The FDA 510(k) record lists Laerdal Medical AS as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Laerdal Medical AS as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: BTM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243861butterflyBVMCompact Medical, Inc.K221841EOlife®ArcheonK212905Sotair DeviceSafe Bvm CorporationK210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd.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.

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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