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, 1988 | K881614 | MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER) Ohmeda Medical | BYE |
| Mar 4, 1988 | K880161 | ACKRAD PEDIATRIC C.P.A.P. SYSTEM Ackrad Laboratories | BYE |
| Feb 29, 1988 | K875073 | BREATHE-FREE Cincinnati Medical Technologies, Inc. | BYE |
| Dec 30, 1987 | K874479 | MC/CPAP MANIFOLD Minneapolis Children'S Services Corp. | BYE |
| Sep 25, 1987 | K873170 | ARIES Mountain Medical Equipment, Inc. | BYE |
| Sep 15, 1987 | K871693 | SLEEP APNEA NASAL CPAP SYSTEM Puritan Bennett Corp. | BYE |
| Sep 1, 1987 | K872202 | ADJUSTABLE PEEP VALVE Med Air Technology, Inc. | BYE |
| Jul 16, 1987 | K871523 | RESPIRONICS SANDERS BIPAPEASY Respironics, Inc. | BYE |
| Jul 14, 1986 | K861758 | CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA Life Design Systems, Inc. | BYE |
| Jun 12, 1986 | K860848 | VITAL FLOW NASAL CPAP SYSTEM Systems 2000, Inc. | BYE |
| Apr 28, 1986 | K861104 | VARIABLE HIGH FLOW DOWNS CPAP GENERATOR Med Air Technology, Inc. | BYE |
| Feb 24, 1986 | K854822 | LDS PEEP VALVE Life Design Systems, Inc. | BYE |
| Jan 15, 1986 | K854458 | CUSHION-FLEX TM-CPAP FACE MASK Life Design Systems, Inc. | BYE |
| May 15, 1985 | K851396 | SANDER'S MASKCPAP BY RESPIRONICS Respironics, Inc. | BYE |
| Apr 15, 1985 | K851194 | AMBU CPAP SYSTEM Ambu, Inc. | BYE |
| Dec 4, 1984 | K843889 | RESPIRONICS SLEEPEASY NASAL CPAP SYS Respironics, Inc. | BYE |
| Nov 15, 1984 | K843835 | OHMEDA PEEP VALVE FOR GMS ABSORBER Ohmeda Medical | BYE |
| Dec 16, 1983 | K834085 | DRAGER PEEP SYSTEM D Draeger Medical, Inc. | BYE |
| Sep 12, 1983 | K831503 | DOWNS ADJUSTABLE FLOW GENERATOR Vital Signs, Inc. | BYE |
| Jun 8, 1983 | K831301 | PEEP SYSTEM D Draeger Medical, Inc. | BYE |
| Mar 11, 1983 | K830395 | PEEPER Dupaco, Inc. | BYE |
| Mar 1, 1982 | K820404 | PEEP VALVE Vital Signs, Inc. | BYE |
| Jan 15, 1981 | K802943 | POSITIVE END EXPIRATORY PRESSURE VALVE Fraser Harlake, Inc. | BYE |
| Nov 12, 1980 | K802707 | DRAGER PEEP CONTROL SYSTEM Draeger Medical, Inc. | BYE |
| Sep 9, 1980 | K802070 | VITAL SIGNS PEEP VALVE Vital Signs, Inc. | BYE |
| May 8, 1980 | K800755 | BOEHRINGER LABS AMBULATORY PEEP VALVE Boehringer Laboratories | BYE |
| Dec 26, 1978 | K782152 | VALVE, AMBU PEEP Narco Air-Shields | BYE |
| Oct 4, 1978 | K781332 | PEEP/CPAP VALVE Vickers America Medical Corp. | BYE |
| May 10, 1977 | K770766 | REGULATOR, PRESSURE, EXPIRATORY Globe Safety Products, Inc. | BYE |
| Aug 6, 1976 | K760230 | VALVE, PEEP Ohio Medical Products | BYE |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.