Product code BYE
- Device name
- Attachment, Breathing, Positive End Expiratory Pressure
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5965
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K160112 | Besmed PEEP Valve | Besmed Health Business Corp | 2016-04-29 |
| K133957 | DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE | Galemed Corp. | 2014-04-14 |
| K133210 | B&B BUBBLER | S & T Medical Technologies, Inc. | 2014-03-28 |
| K122610 | PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES | Sen MU Technology Co., Ltd. | 2013-08-05 |
| K112546 | O_TWO CPAP SYSTEM | O-Two Medical Technologies, Inc. | 2011-12-27 |
| K110713 | WATERPAP VALVE | Airways Development, LLC | 2011-09-12 |
| K103833 | NEOPIP PATIENT CIRCUIT WITH PEEP | Neoforce Group, Inc. | 2011-04-20 |
| K092029 | VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 | Draeger Medical AG & Co. KG | 2010-08-06 |
| K090710 | MERCURY CPAP | Mercury Medical | 2009-08-20 |
| K090317 | BABI*PLUS BUBBLE PAP VALVE | A Plus Medical | 2009-05-20 |
| K081266 | MERCURY MEDICAL PEEP VALVE | Mercury Enterprizes Dba Mercury Medical | 2009-03-05 |
| K080256 | PULMODYNE CHF FLOW GENERATOR SYSTEM | Pulmodyne | 2008-05-09 |
| K070416 | NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP | Neoforce Group, Inc. | 2007-05-29 |
| K050918 | KOO AMERICAS VALVE PEEP, MODEL KM-809 | Koo Americas, Inc. | 2005-06-06 |
| K013884 | BOUSSIGNAC C.P.A.P. DEVICE | Vygon SA | 2003-01-21 |
| K001318 | CPAP SYSTEM, MODEL 102001 | Sims Portex, Inc. | 2000-07-20 |
| K982283 | WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH | Caradyne, Ltd. | 1999-03-09 |
| K983920 | EMS PEEP VALVES- ADJUSTABLE | Engineered Medical Systems | 1999-01-22 |
| K981415 | 0-20 CM H20 PEEP VALVE | Cheen Houng Ent. Co. , Ltd. | 1998-07-14 |
| K963347 | REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 | Instrumentation Industries, Inc. | 1997-03-19 |
| K962492 | SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM | Nidek Medical Products, Inc. | 1997-01-23 |
| K961867 | PEEP VALVE | Medical Marketing Concepts | 1996-08-13 |
| K955047 | WESTMED CIRCULARIE PEP DEVICES | Westmed Intl. | 1996-03-27 |
| K953511 | KENDALL SHERIDAN CPAP SYSTEM | Kendall Healthcare Products Co. Div.Of Tyco Health | 1995-10-26 |
| K953485 | SIMS CPAP SYSTEM | Smiths Industries Medical Systems, Inc. | 1995-10-26 |
| K950397 | SYSTEM 22 VALVE | Turnkey Intergration USA, Inc. | 1995-04-14 |
| K942246 | PURITAN-BENNETT NASAL CPAP MASK | Puritan-Bennett | 1994-07-06 |
| K932799 | SINGLE USE MANUAL RESUSCITATOR PEEP VALVE | Engineered Medical Systems | 1993-09-03 |
| K923976 | AMBU SINGLE PATIENT USE PEEP VALVE | Ambu, Inc. | 1993-01-05 |
| K923618 | PEEP VALVE | International Respiratory Systems, Inc. | 1992-08-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08498840012130 | VYGON | Vygon Corporation | 2020-03-12 |
| 10190752145092 | AirLife™ | AIRLIFE | 2020-01-15 |
| 10190752133181 | AirLife™ | AIRLIFE | 2020-01-15 |
| 10190752133198 | AirLife™ | AIRLIFE | 2020-01-15 |
| 10190752133204 | AirLife™ | AIRLIFE | 2020-01-15 |
| 10190752133211 | AirLife™ | AIRLIFE | 2020-01-15 |
| 10190752145078 | AirLife™ | AIRLIFE | 2020-01-15 |
| 10190752145085 | AirLife™ | AIRLIFE | 2020-01-15 |
| 10641043553268 | Flow-Safe Disposable CPAP System Tubing Kit | MERCURY ENTERPRISES, INC. | 2018-08-31 |
| 10641043553107 | PEEP Valve | MERCURY ENTERPRISES, INC. | 2018-04-15 |
| 08498840009840 | VYGON | Vygon Corporation | 2016-09-06 |
| 08498840000441 | VYGON | Vygon Corporation | 2016-09-02 |
| 08498840000458 | VYGON | Vygon Corporation | 2016-09-02 |
| 08498840000465 | VYGON | Vygon Corporation | 2016-09-02 |
| 08498840000434 | VYGON | Vygon Corporation | 2016-09-02 |
| 10641043570135 | Flow-Safe Disposable CPAP System | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043570128 | Flow-Safe Disposable CPAP System | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043570111 | Flow-Safe Disposable CPAP System | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043570104 | Flow-Safe Disposable CPAP System | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043570098 | Flow-Safe Disposable CPAP System | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043570081 | Flow-Safe Disposable CPAP System | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043570074 | Flow-Safe Disposable CPAP System | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043570067 | Flow-Safe Disposable CPAP System | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043570036 | Flow-Safe Disposable CPAP System | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043570029 | Flow-Safe Disposable CPAP System | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043570012 | Flow-Safe Disposable CPAP System | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043570005 | Flow-Safe Disposable CPAP System | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043553312 | PEEP Valve | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043553305 | PEEP Valve | MERCURY ENTERPRISES, INC. | 2015-09-24 |
| 10641043553152 | PEEP Valve | MERCURY ENTERPRISES, INC. | 2015-09-24 |