Panels › Anesthesiology › Product code BYE · Class 2
Attachment, Breathing, Positive End Expiratory Pressure
Regulation 868.5965
0510(k)s in 12 months (80 all time)
1recalls in 12 months (11 all time)
7recalls that name a 510(k)
Top companies in BYE
| Company | 510(k)s | Recalls |
|---|---|---|
| Ambu, Inc. | 2 | 4 |
| Puritan Bennett Corp. | 6 | 0 |
| Vital Signs, Inc. | 6 | 0 |
| Respironics, Inc. | 5 | 0 |
| Draeger Medical AG & Co. KG | 4 | 0 |
| Devilbiss Health Care, Inc. | 3 | 0 |
| Life Design Systems, Inc. | 3 | 0 |
| Westmed, Inc. | 0 | 3 |
| Airways Development, LLC | 1 | 1 |
| Engineered Medical Systems | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 29, 2016 | K160112 | Besmed PEEP Valve Besmed Health Business Corp, TW | BYE |
| Apr 14, 2014 | K133957 | DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE Galemed Corp., CN | BYE |
| Mar 28, 2014 | K133210 | B&B BUBBLER S & T Medical Technologies, Inc. | BYE |
| Aug 5, 2013 | K122610 | PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES Sen MU Technology Co., Ltd., TW | BYE |
| Dec 27, 2011 | K112546 | O_TWO CPAP SYSTEM O-Two Medical Technologies, Inc., CA | BYE |
| Sep 12, 2011 | K110713 | WATERPAP VALVE Airways Development, LLC | BYE |
| Apr 20, 2011 | K103833 | NEOPIP PATIENT CIRCUIT WITH PEEP Neoforce Group, Inc. | BYE |
| Aug 6, 2010 | K092029 | VENTSTAR RESUSCITAIRE, MODEL MP00311, VENTSTAR RESUSCITAIRE CEU, MODEL MP00310 Draeger Medical AG & Co. KG | BYE |
| Aug 20, 2009 | K090710 | MERCURY CPAP Mercury Medical | BYE |
| May 20, 2009 | K090317 | BABI*PLUS BUBBLE PAP VALVE A Plus Medical | BYE |
| Mar 5, 2009 | K081266 | MERCURY MEDICAL PEEP VALVE Mercury Enterprizes Dba Mercury Medical | BYE |
| May 9, 2008 | K080256 | PULMODYNE CHF FLOW GENERATOR SYSTEM Pulmodyne | BYE |
| May 29, 2007 | K070416 | NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP Neoforce Group, Inc. | BYE |
| Jun 6, 2005 | K050918 | KOO AMERICAS VALVE PEEP, MODEL KM-809 Koo Americas, Inc. | BYE |
| Jan 21, 2003 | K013884 | BOUSSIGNAC C.P.A.P. DEVICE Vygon SA | BYE |
| Jul 20, 2000 | K001318 | CPAP SYSTEM, MODEL 102001 Sims Portex, Inc. | BYE |
| Mar 9, 1999 | K982283 | WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH Caradyne, Ltd. | BYE |
| Jan 22, 1999 | K983920 | EMS PEEP VALVES- ADJUSTABLE Engineered Medical Systems | BYE |
| Jul 14, 1998 | K981415 | 0-20 CM H20 PEEP VALVE Cheen Houng Ent. Co. , Ltd., TW | BYE |
| Mar 19, 1997 | K963347 | REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 Instrumentation Industries, Inc. | BYE |
| Jan 23, 1997 | K962492 | SILENZIO PLUS CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM Nidek Medical Products, Inc. | BYE |
| Aug 13, 1996 | K961867 | PEEP VALVE Medical Marketing Concepts | BYE |
| Mar 27, 1996 | K955047 | WESTMED CIRCULARIE PEP DEVICES Westmed Intl. | BYE |
| Oct 26, 1995 | K953511 | KENDALL SHERIDAN CPAP SYSTEM Kendall Healthcare Products Co. Div.Of Tyco Health | BYE |
| Oct 26, 1995 | K953485 | SIMS CPAP SYSTEM Smiths Industries Medical Systems, Inc. | BYE |
| Apr 14, 1995 | K950397 | SYSTEM 22 VALVE Turnkey Intergration USA, Inc. | BYE |
| Jul 6, 1994 | K942246 | PURITAN-BENNETT NASAL CPAP MASK Puritan-Bennett | BYE |
| Sep 3, 1993 | K932799 | SINGLE USE MANUAL RESUSCITATOR PEEP VALVE Engineered Medical Systems | BYE |
| Jan 5, 1993 | K923976 | AMBU SINGLE PATIENT USE PEEP VALVE Ambu, Inc. | BYE |
| Aug 3, 1992 | K923618 | PEEP VALVE International Respiratory Systems, Inc. | BYE |
| May 29, 1992 | K922178 | COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION Puritan Bennett Corp. | BYE |
| Sep 11, 1991 | K912578 | 20CM/H20 PEEP VALVE Vital Signs, Inc. | BYE |
| Aug 22, 1991 | K912240 | CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM Mallinckrodt Anesthesia Products | BYE |
| Jan 8, 1991 | K904874 | ADJUSTABLE PEEP VALVE Vital Signs, Inc. | BYE |
| Sep 10, 1990 | K903764 | COMPANION 318 NASAL CPAP SYSTEM Puritan Bennett Corp. | BYE |
| Sep 4, 1990 | K903125 | PURITAN BENNETT SINGLE PATIENT USE PEEP VALVE Puritan Bennett Corp. | BYE |
| Sep 4, 1990 | K902062 | PEEP VALVE Hudson Oxygen Therapy Sales Co. | BYE |
| Aug 14, 1990 | K901728 | ONE-LUNG CPAP DEVICE Vital Signs, Inc. | BYE |
| Mar 28, 1990 | K900113 | RESPIRONICS' REMSTAR(TM) SLEEPEASY Respironics, Inc. | BYE |
| Jan 26, 1990 | K900164 | AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA. Puritan Bennett Corp. | BYE |
| Jan 12, 1990 | K894779 | LIFECARE NASAL MASK KIT CAT. NO. 06-800 Lifecare Services, Inc. | BYE |
| Nov 15, 1989 | K895360 | C.P.A.P. VALVE AND C.P.P.A. KIT Ballard Medical Products | BYE |
| Sep 18, 1989 | K894424 | DEVILBISS MODEL 7351 SERIES Devilbiss Health Care, Inc. | BYE |
| Sep 8, 1989 | K894690 | CPAP MASK Devilbiss Health Care, Inc. | BYE |
| Jun 23, 1989 | K893388 | DEVILBISS MODEL 7351D REVITALIZER CPAP SYSTEM Devilbiss Health Care, Inc. | BYE |
| Jun 1, 1989 | K891540 | EDENTEC MODEL 2860 PRESSURE METER Edentec Corp. | BYE |
| Dec 8, 1988 | K883825 | MODIFIED SANDERS BI-PAPEASY Respironics, Inc. | BYE |
| Aug 30, 1988 | K882219 | P.E.E.P. VALVE Life Support Products, Inc. | BYE |
| Jun 24, 1988 | K881833 | NASAL CPAP SYSTEM Healthdyne, Inc. | BYE |
| Jun 21, 1988 | K882292 | SULLIVAN NASAL CPAP SYSTEM Baxter Centre For Medical Research, AU | BYE |
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