Attachment, Breathing, Positive End Expiratory Pressure
FDA product code BYE · Class II (moderate risk) · 21 CFR 868.5965 · Anesthesiology
80510(k) clearances
0PMA approvals
10recalls
Manufacturers
- Puritan Bennett Corp. 6
- Vital Signs, Inc. 6
- Respironics, Inc. 5
- Draeger Medical, Inc. 4
- Devilbiss Health Care, Inc. 3
- Life Design Systems, Inc. 3
- Ohmeda Medical 2
- Ambu, Inc. 2
- Med Air Technology, Inc. 2
- Neoforce Group, Inc. 2
- Engineered Medical Systems 2
- Besmed Health Business Corp 1
- Fraser Harlake, Inc. 1
- Dupaco, Inc. 1
- Narco Air-Shields 1
- Vickers America Medical Corp. 1
- Systems 2000, Inc. 1
- Globe Safety Products, Inc. 1
- Minneapolis Children'S Services Corp. 1
- Cincinnati Medical Technologies, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K160112 | Besmed PEEP ValveBYE · Traditional | Besmed Health Business Corp | 04/29/2016SE |
| K133957 | Disposable Adjustable Peep Valve MR Conditional UseBYE · Traditional | Galemed Corp. | 04/14/2014SE |
| K133210 | B&B BubblerBYE · Traditional | S & T Medical Technologies, Inc. | 03/28/2014SE |
| K122610 | Plaxtron CPAP System, Model CH-FFM-87XX/CH-FFM-88XX SeriesBYE · Traditional | Sen MU Technology Co., Ltd. | 08/05/2013SE |
| K112546 | O_Two CPAP SystemBYE · Traditional | O-Two Medical Technologies, Inc. | 12/27/2011SE |
| K110713 | Waterpap ValveBYE · Traditional | Airways Development, LLC | 09/12/2011SE |
| K103833 | Neopip Patient Circuit with PeepBYE · Traditional | Neoforce Group, Inc. | 04/20/2011SE |
| K092029 | Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310BYE · Traditional | Draeger Medical AG & Co. KG | 08/06/2010SE |
| K090710 | Mercury CPAPBYE · Traditional | Mercury Medical | 08/20/2009SE |
| K090317 | Babi*Plus Bubble Pap ValveBYE · Traditional | A Plus Medical | 05/20/2009SE |
| K081266 | Mercury Medical Peep ValveBYE · Traditional | Mercury Enterprizes Dba Mercury Medical | 03/05/2009SE |
| K080256 | Pulmodyne CHF Flow Generator SystemBYE · Traditional | Pulmodyne | 05/09/2008SE |
| K070416 | Neopeep Neonatal Resuscitation Circuit with PeepBYE · Traditional | Neoforce Group, Inc. | 05/29/2007SE |
| K050918 | Koo Americas Valve Peep, Model KM-809BYE · Traditional | Koo Americas, Inc. | 06/06/2005SE |
| K013884 | Boussignac C.P.A.P. DeviceBYE · Traditional | Vygon SA | 01/21/2003SE |
| K001318 | CPAP System, Model 102001BYE · Traditional | Sims Portex, Inc. | 07/20/2000SE |
| K982283 | Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow Oxygen Flow…BYE · Traditional | Caradyne, Ltd. | 03/09/1999SE |
| K983920 | EMS Peep Valves- AdjustableBYE · Traditional | Engineered Medical Systems | 01/22/1999SE |
| K981415 | 0-20 CM H20 Peep ValveBYE · Traditional | Cheen Houng Ent. Co. , Ltd. | 07/14/1998SE |
| K963347 | Reusable, Adjustable, Magnetic Peep Valve Be 142BYE · Traditional | Instrumentation Industries, Inc. | 03/19/1997SE |
| K962492 | Silenzio Plus Continuous Positive Airway Pressure SystemBYE · Traditional | Nidek Medical Products, Inc. | 01/23/1997SE |
| K961867 | Peep ValveBYE · Traditional | Medical Marketing Concepts | 08/13/1996SE |
| K955047 | Westmed Circularie Pep DevicesBYE · Traditional | Westmed Intl. | 03/27/1996SE |
| K953511 | Kendall Sheridan CPAP SystemBYE · Traditional | Kendall Healthcare Products Co. Div.Of Tyco Health | 10/26/1995SESK |
| K953485 | Sims CPAP SystemBYE · Traditional | Smiths Industries Medical Systems, Inc. | 10/26/1995SE |
| K950397 | System 22 ValveBYE · Traditional | Turnkey Intergration USA, Inc. | 04/14/1995SE |
| K942246 | Puritan-Bennett Nasal CPAP MaskBYE · Traditional | Puritan-Bennett | 07/06/1994SE |
| K932799 | Single Use Manual Resuscitator Peep ValveBYE · Traditional | Engineered Medical Systems | 09/03/1993SE |
| K923976 | Ambu Single Patient Use Peep ValveBYE · Traditional | Ambu, Inc. | 01/05/1993SE |
| K923618 | Peep ValveBYE · Traditional | International Respiratory Systems, Inc. | 08/03/1992SE |
| K922178 | Companion 318 Nasal CPAP System -- ModificationBYE · Traditional | Puritan Bennett Corp. | 05/29/1992SE |
| K912578 | 20CM/H20 Peep ValveBYE · Traditional | Vital Signs, Inc. | 09/11/1991SE |
| K912240 | CPAP System and Broncho-Cath W/Cpap SystemBYE · Traditional | Mallinckrodt Anesthesia Products | 08/22/1991SE |
| K904874 | Adjustable Peep ValveBYE · Traditional | Vital Signs, Inc. | 01/08/1991SE |
| K903764 | Companion 318 Nasal CPAP SystemBYE · Traditional | Puritan Bennett Corp. | 09/10/1990SE |
| K903125 | Puritan Bennett Single Patient Use Peep ValveBYE · Traditional | Puritan Bennett Corp. | 09/04/1990SE |
| K902062 | Peep ValveBYE · Traditional | Hudson Oxygen Therapy Sales Co. | 09/04/1990SE |
| K901728 | One-Lung CPAP DeviceBYE · Traditional | Vital Signs, Inc. | 08/14/1990SE |
| K900113 | Respironics' Remstar(Tm) SleepeasyBYE · Traditional | Respironics, Inc. | 03/28/1990SE |
| K900164 | Airway Delivery & Management (Adam) Nasal Ventila.BYE · Traditional | Puritan Bennett Corp. | 01/26/1990SE |
| K894779 | Lifecare Nasal Mask Kit Cat. No. 06-800BYE · Traditional | Lifecare Services, Inc. | 01/12/1990SE |
| K895360 | C.P.A.P. Valve and C.P.P.A. KitBYE · Traditional | Ballard Medical Products | 11/15/1989SE |
| K894424 | Devilbiss Model 7351 SeriesBYE · Traditional | Devilbiss Health Care, Inc. | 09/18/1989SE |
| K894690 | CPAP MaskBYE · Traditional | Devilbiss Health Care, Inc. | 09/08/1989SE |
| K893388 | Devilbiss Model 7351D Revitalizer CPAP SystemBYE · Traditional | Devilbiss Health Care, Inc. | 06/23/1989SE |
| K891540 | Edentec Model 2860 Pressure MeterBYE · Traditional | Edentec Corp. | 06/01/1989SE |
| K883825 | Modified Sanders Bi-PapeasyBYE · Traditional | Respironics, Inc. | 12/08/1988SE |
| K882219 | P.E.E.P. ValveBYE · Traditional | Life Support Products, Inc. | 08/30/1988SE |
| K881833 | Nasal CPAP SystemBYE · Traditional | Healthdyne, Inc. | 06/24/1988SE |
| K882292 | Sullivan Nasal CPAP SystemBYE · Traditional | Baxter Centre For Medical Research | 06/21/1988SE |
| K881614 | Modified Ohmeda Peep Valve (for GMS Absorber)BYE · Traditional | Ohmeda Medical | 04/29/1988SE |
| K880161 | Ackrad Pediatric C.P.A.P. SystemBYE · Traditional | Ackrad Laboratories | 03/04/1988SE |
| K875073 | Breathe-FreeBYE · Traditional | Cincinnati Medical Technologies, Inc. | 02/29/1988SE |
| K874479 | Mc/Cpap ManifoldBYE · Traditional | Minneapolis Children'S Services Corp. | 12/30/1987SE |
| K873170 | AriesBYE · Traditional | Mountain Medical Equipment, Inc. | 09/25/1987SE |
| K871693 | Sleep Apnea Nasal CPAP SystemBYE · Traditional | Puritan Bennett Corp. | 09/15/1987SE |
| K872202 | Adjustable Peep ValveBYE · Traditional | Med Air Technology, Inc. | 09/01/1987SE |
| K871523 | Respironics Sanders BipapeasyBYE · Traditional | Respironics, Inc. | 07/16/1987SE |
| K861758 | Cushion-Flex TM Nasal CPAP Mask for Sleep ApneaBYE · Traditional | Life Design Systems, Inc. | 07/14/1986SE |
| K860848 | Vital Flow Nasal CPAP SystemBYE · Traditional | Systems 2000, Inc. | 06/12/1986SE |
| K861104 | Variable High Flow Downs CPAP GeneratorBYE · Traditional | Med Air Technology, Inc. | 04/28/1986SE |
| K854822 | LDS Peep ValveBYE · Traditional | Life Design Systems, Inc. | 02/24/1986SE |
| K854458 | Cushion-Flex Tm-Cpap Face MaskBYE · Traditional | Life Design Systems, Inc. | 01/15/1986SE |
| K851396 | Sander's Maskcpap by RespironicsBYE · Traditional | Respironics, Inc. | 05/15/1985SE |
| K851194 | Ambu CPAP SystemBYE · Traditional | Ambu, Inc. | 04/15/1985SE |
| K843889 | Respironics Sleepeasy Nasal CPAP SysBYE · Traditional | Respironics, Inc. | 12/04/1984SE |
| K843835 | Ohmeda Peep Valve for GMS AbsorberBYE · Traditional | Ohmeda Medical | 11/15/1984SE |
| K834085 | Drager Peep System DBYE · Traditional | Draeger Medical, Inc. | 12/16/1983SE |
| K831503 | Downs Adjustable Flow GeneratorBYE · Traditional | Vital Signs, Inc. | 09/12/1983SE |
| K831301 | Peep System DBYE · Traditional | Draeger Medical, Inc. | 06/08/1983SE |
| K830395 | PeeperBYE · Traditional | Dupaco, Inc. | 03/11/1983SE |
| K820404 | Peep ValveBYE · Traditional | Vital Signs, Inc. | 03/01/1982SE |
| K802943 | Positive End Expiratory Pressure ValveBYE · Traditional | Fraser Harlake, Inc. | 01/15/1981SE |
| K802707 | Drager Peep Control SystemBYE · Traditional | Draeger Medical, Inc. | 11/12/1980SE |
| K802070 | Vital Signs Peep ValveBYE · Traditional | Vital Signs, Inc. | 09/09/1980SE |
| K800755 | Boehringer Labs Ambulatory Peep ValveBYE · Traditional | Boehringer Laboratories | 05/08/1980SE |
| K782152 | Valve, Ambu PeepBYE · Traditional | Narco Air-Shields | 12/26/1978SESP |
| K781332 | Peep/Cpap ValveBYE · Traditional | Vickers America Medical Corp. | 10/04/1978SE |
| K770766 | Regulator, Pressure, ExpiratoryBYE · Traditional | Globe Safety Products, Inc. | 05/10/1977SE |
| K760230 | Valve, PeepBYE · Traditional | Ohio Medical Products | 08/06/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2436-2020 Class II | Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on…A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections… | Westmed, Inc. | 01/15/2019Terminated |
| Z-2435-2020 Class II | Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on…A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections… | Westmed, Inc. | 01/15/2019Terminated |
| Z-2434-2020 Class II | Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant…A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections… | Westmed, Inc. | 01/15/2019Terminated |
| Z-0552-2016 Class II | Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A. During a… | Airways Development LLC | 09/24/2015Terminated |
| Z-1380-2008 | Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure…Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due… | Smiths Medical ASD, Inc. | 03/04/2008Terminated |
| Z-1379-2008 | Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end…Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due… | Smiths Medical ASD, Inc. | 03/04/2008Terminated |
| Z-0536-2008 | Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve Spare Part, REF 137 000…Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow… | Ambu Incorporated | 08/21/2007Terminated |
| Z-0535-2008 | Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, 30mm…Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow… | Ambu Incorporated | 08/21/2007Terminated |
| Z-0534-2008 | Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, REF 000…Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow… | Ambu Incorporated | 08/21/2007Terminated |
| Z-0533-2008 | Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, REF 000 137…Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow… | Ambu Incorporated | 08/21/2007Terminated |