Peep Valve

FDA 510(k) K923618 · International Respiratory Systems, Inc.

Substantially Equivalent

510(k) numberK923618

Submission

Device name
Peep Valve
Applicant
International Respiratory Systems, Inc.
Newburgh, NY, US
Received
July 21, 1992
Decision date
August 3, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BYE – Attachment, Breathing, Positive End Expiratory Pressure
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5965
Specialty
Anesthesiology
Life-sustaining
Yes

Other 510(k)s with product code BYE

510(k)DeviceApplicantDecision
K160112Besmed PEEP ValveBYE · Traditional Besmed Health Business Corp04/29/2016SE
K133957Disposable Adjustable Peep Valve MR Conditional UseBYE · Traditional Galemed Corp.04/14/2014SE
K133210B&B BubblerBYE · Traditional S & T Medical Technologies, Inc.03/28/2014SE
K122610Plaxtron CPAP System, Model CH-FFM-87XX/CH-FFM-88XX SeriesBYE · Traditional Sen MU Technology Co., Ltd.08/05/2013SE
K112546O_Two CPAP SystemBYE · Traditional O-Two Medical Technologies, Inc.12/27/2011SE
K110713Waterpap ValveBYE · Traditional Airways Development, LLC09/12/2011SE
K103833Neopip Patient Circuit with PeepBYE · Traditional Neoforce Group, Inc.04/20/2011SE
K092029Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310BYE · Traditional Draeger Medical AG & Co. KG08/06/2010SE
K090710Mercury CPAPBYE · Traditional Mercury Medical08/20/2009SE
K090317Babi*Plus Bubble Pap ValveBYE · Traditional A Plus Medical05/20/2009SE

More from A Plus Medical

510(k)DeviceDecision
K981308International Respiratory Systems, Inc.'s Manual Pulmonary Resuscitator with Rubber…BTM · Traditional 07/06/1998SE
K981307International Respiratory Systems, Inc.'s Manual ResusciatorBTM · Traditional 07/06/1998SE

Questions and answers

When was Peep Valve cleared by the FDA?

Peep Valve (K923618) received a 510(k) decision of Substantially Equivalent on August 3, 1992, 13 days after the submission was received.

What is the product code of K923618?

The FDA product code is BYE – Attachment, Breathing, Positive End Expiratory Pressure, a Class II (moderate risk) device regulated under 21 CFR 868.5965.