Pulmanex (TM)

FDA 510(k) K860693 · Life Design Systems, Inc.

Substantially Equivalent

510(k) numberK860693

Submission

Device name
Pulmanex (TM)
Applicant
Life Design Systems, Inc.
Milwaukee, WI, US
Received
February 25, 1986
Decision date
March 27, 1986
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

510(k)DeviceApplicantDecision
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
K913714Modification Manual Pulmon Resuscitor/Pulmanex(Tm)BTM · Traditional 12/01/1992SE
K885313Humidi-Flex TMBYD · Traditional 10/11/1989SE
K893030Child Size - Filter Flex (TM)CAH · Traditional 09/18/1989SE
K892862Flex-Cup PercussorBYI · Traditional 05/25/1989SE
K892221Pulmonary Resuscitator, ModificationBTM · Traditional 05/18/1989SE
K890011Oxygen Connector and Oxygen Delivery TubingBZO · Traditional 03/20/1989SE
K890108Modified Cushion-Flex(Tm)BSJ · Traditional 01/24/1989SE
K884387Cushion Flex(Tm)BSJ · Traditional 11/17/1988SE
K884068Pulmanex TM (Neo-Natal Size)BTM · Traditional 11/16/1988SE
K873179Heater Wire Breathing CircuitBZE · Traditional 03/31/1988SE

Questions and answers

When was Pulmanex (TM) cleared by the FDA?

Pulmanex (TM) (K860693) received a 510(k) decision of Substantially Equivalent on March 27, 1986, 30 days after the submission was received.

What is the product code of K860693?

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