BYE · Attachment, Breathing, Positive End Expiratory Pressure
Anesthesiology · 21 CFR 868.5965 · Class 2
Overview
| Product Code | BYE |
|---|---|
| Device Name | Attachment, Breathing, Positive End Expiratory Pressure |
| Regulation | 21 CFR 868.5965 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 80)
Showing 20 most recent of 80 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K160112 | Besmed PEEP Valve | Besmed Health Business Corp | Apr 29, 2016 | SESE |
| K133957 | DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE | Galemed Corp. | Apr 14, 2014 | SESE |
| K133210 | B&B BUBBLER | S & T Medical Technologies, Inc. | Mar 28, 2014 | SESE |
| K122610 | PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES | Sen MU Technology Co., Ltd. | Aug 5, 2013 | SESE |
| K112546 | O_TWO CPAP SYSTEM | O-Two Medical Technologies, Inc. | Dec 27, 2011 | SESE |
| K110713 | WATERPAP VALVE | Airways Development, LLC | Sep 12, 2011 | SESE |
| K103833 | NEOPIP PATIENT CIRCUIT WITH PEEP | Neoforce Group, Inc. | Apr 20, 2011 | SESE |
| K092029 | VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 | Draeger Medical AG & Co. KG | Aug 6, 2010 | SESE |
| K090710 | MERCURY CPAP | Mercury Medical | Aug 20, 2009 | SESE |
| K090317 | BABI*PLUS BUBBLE PAP VALVE | A Plus Medical | May 20, 2009 | SESE |
| K081266 | MERCURY MEDICAL PEEP VALVE | Mercury Enterprizes Dba Mercury Medical | Mar 5, 2009 | SESE |
| K080256 | PULMODYNE CHF FLOW GENERATOR SYSTEM | Pulmodyne | May 9, 2008 | SESE |
| K070416 | NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP | Neoforce Group, Inc. | May 29, 2007 | SESE |
| K050918 | KOO AMERICAS VALVE PEEP, MODEL KM-809 | Koo Americas, Inc. | Jun 6, 2005 | SESE |
| K013884 | BOUSSIGNAC C.P.A.P. DEVICE | Vygon SA | Jan 21, 2003 | SESE |
| K001318 | CPAP SYSTEM, MODEL 102001 | Sims Portex, Inc. | Jul 20, 2000 | SESE |
| K982283 | WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH | Caradyne, Ltd. | Mar 9, 1999 | SESE |
| K983920 | EMS PEEP VALVES- ADJUSTABLE | Engineered Medical Systems | Jan 22, 1999 | SESE |
| K981415 | 0-20 CM H20 PEEP VALVE | Cheen Houng Ent. Co. , Ltd. | Jul 14, 1998 | SESE |
| K963347 | REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 | Instrumentation Industries, Inc. | Mar 19, 1997 | SESE |
Top Applicants
- Vital Signs, Inc. — 6 clearances
- Puritan Bennett Corp. — 5 clearances
- Respironics, Inc. — 5 clearances
- Devilbiss Health Care, Inc. — 3 clearances
- Draeger Medical, Inc. — 3 clearances
