Manual Disposable Pulmonary Resuscitator

FDA 510(k) K895169 · F.L.W. Plastics, Inc.

Substantially Equivalent

510(k) numberK895169

Submission

Device name
Manual Disposable Pulmonary Resuscitator
Applicant
F.L.W. Plastics, Inc.
Columbus, IN, US
Received
August 10, 1989
Decision date
October 13, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K132172Neonatalie ResuscitatorBTM · Abbreviated Laerdal Medical A/S01/15/2015SE
K112852Babi Plus Neonatal Resuscitation BagBTM · Traditional A Plus Medical01/13/2012SE

More from A Plus Medical

510(k)DeviceDecision
K900291Mass Spectrometry Monitoring Lines and ConnectorsCCK · Traditional 03/28/1990SE
K895233Bacterial and Viral FilterCAH · Traditional 11/15/1989SE
K895357Anethesia Breathing CircuitCAI · Traditional 10/19/1989SE

Questions and answers

When was Manual Disposable Pulmonary Resuscitator cleared by the FDA?

Manual Disposable Pulmonary Resuscitator (K895169) received a 510(k) decision of Substantially Equivalent on October 13, 1989, 64 days after the submission was received.

What is the product code of K895169?

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