Neonatalie Resuscitator

FDA 510(k) K132172 · Laerdal Medical A/S

Substantially Equivalent

510(k) numberK132172

Submission

Device name
Neonatalie Resuscitator
Applicant
Laerdal Medical A/S
Stavanger, NO
Received
July 15, 2013
Decision date
January 15, 2015
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTM – Ventilator, Emergency, Manual (Resuscitator)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5915
Specialty
Anesthesiology
Life-sustaining
Yes

Other 510(k)s with product code BTM

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K251631The BAG manual resuscitator and accessoriesBTM · Traditional Laerdal Medical AS11/24/2025SE
K243861butterflyBVMBTM · Traditional Compact Medical, Inc.04/25/2025SE
K221841EOlife®BTM · Traditional Archeon03/18/2023SE
K212905Sotair DeviceBTM · Traditional Safe Bvm Corporation08/18/2022SE
K210288Disposable Manual ResuscitatorBTM · Traditional Xiamen Compower Medical Tech. Co., Ltd.08/26/2021SE
K181583Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator…BTM · Traditional Flexicare Medical Limited.12/07/2018SE
K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount…BTM · Traditional Foremount Enterprise Co., Ltd.05/11/2018SE
K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II…BTM · Abbreviated Ambu A/S08/29/2016SE
K112852Babi Plus Neonatal Resuscitation BagBTM · Traditional A Plus Medical01/13/2012SE
K102824Ambu Oval Silicone Resuscitator, Adult and PediatricBTM · Abbreviated Ambu A/S01/28/2011SE

More from Ambu A/S

510(k)DeviceDecision
K122050Cprmeter CPR Feedback DeviceLIX · Traditional 10/22/2012SE
K023805Laerdal Paediatric Pocket Mask, Model 820050CBP · Special 02/11/2003SE
K993668Laerdal Suction UNIT,(4000) Model 78 00 20BTA · Traditional 12/20/1999SE

Questions and answers

When was Neonatalie Resuscitator cleared by the FDA?

Neonatalie Resuscitator (K132172) received a 510(k) decision of Substantially Equivalent on January 15, 2015, 549 days after the submission was received.

What is the product code of K132172?

The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.