Panels › Anesthesiology › Product code CBK · Class 2
Ventilator, Continuous, Facility Use
Regulation 868.5895
4510(k)s in 12 months (505 all time)
23recalls in 12 months (336 all time)
306recalls that name a 510(k)
Top companies in CBK
| Company | 510(k)s | Recalls |
|---|---|---|
| Hamilton Medical AG | 35 | 31 |
| Philips Respironics | 0 | 54 |
| Draeger Medical AG & Co. KG | 14 | 26 |
| Puritan Bennett Corp. | 34 | 1 |
| Newport Medical Instruments, Inc. | 17 | 12 |
| Respironics, Inc. | 14 | 14 |
| Covidien | 4 | 23 |
| Bird Products Corp. | 21 | 0 |
| Respironics California, Inc. | 8 | 13 |
| Bio-Med Devices, Inc. | 9 | 8 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 16, 1982 | K821930 | SECHRIST MODEL 990 JET VENTILATOR Sechrist Industries, Inc. | CBK |
| Aug 2, 1982 | K821792 | NEUMOVENT 980 Ultramar Marketing Corp. | CBK |
| Jul 26, 1982 | K822103 | MODEL M3000XA VENTILATOR SPECIFICA Thompson Respiration Products, Inc. | CBK |
| Jun 29, 1982 | K821376 | OHIO 7000 ELECTRONIC ANESTHESIA VENTIL. Ohio Medical Products | CBK |
| Apr 16, 1982 | K820746 | NEWPORT VENTILATOR MODEL E100 Newport Medical Instruments, Inc. | CBK |
| Apr 16, 1982 | K820248 | RODDER VOLUME VENTILATOR Pharmaquest Corp. | CBK |
| Mar 26, 1982 | K812961 | SHEFFIELD INFANT VENTILATOR MARK 4 Cairco , Ltd. | CBK |
| Mar 12, 1982 | K820393 | ANESTHESIA VENTILATOR Puritan Bennett Corp. | CBK |
| Feb 18, 1982 | K820220 | VENTILATOR MODELS Pneupac , Ltd. | CBK |
| Feb 4, 1982 | K813254 | JET VENTILATOR Healthdyne, Inc. | CBK |
| Jan 28, 1982 | K820132 | BABYBIRD 2 VENTILATOR 3M Company | CBK |
| Jan 7, 1982 | K812958 | EAST-FREEMAN VENTILATOR MARK 2 Cairco , Ltd. | CBK |
| Dec 30, 1981 | K812016 | VS600 JET VENTILATOR Instrument Development Corp. | CBK |
| Dec 9, 1981 | K813253 | IC-5 VENTILATOR Bio-Med Devices, Inc. | CBK |
| Nov 27, 1981 | K812953 | RADCLIFFE VENTILATOR MARK 5 Cairco , Ltd. | CBK |
| Nov 6, 1981 | K812980 | MA-2 VENTILATOR Bio-Medical Repair, Inc. | CBK |
| Nov 5, 1981 | K812642 | ENGSTROM ERICA Lkb Instruments, Inc. | CBK |
| Jun 18, 1981 | K810893 | HEWLETT-PACKARD VENTILATOR Hewlett-Packard Co. | CBK |
| Jun 12, 1981 | K811141 | SECHRIST INFANT VENTRILATOR MODEL IV-100 Sechrist Industries, Inc. | CBK |
| May 5, 1981 | K811102 | SIEMENS-ELEMA AB SERVO VENTILATOR 900 C Siemens Elema AB | CBK |
| Dec 20, 1980 | K802168 | DRAGER AV2 ANESTHESIA VENTILATOR Draeger Medical, Inc. | CBK |
| Dec 18, 1980 | K802583 | INFANT VENTILATOR, (RESPIRATOR) PLAN B Healthdyne, Inc. | CBK |
| Nov 18, 1980 | K801890 | IC-2 VENTILATOR Bio-Med Devices, Inc. | CBK |
| Oct 3, 1980 | K802270 | PROTECTIVE BAR FOR THE MA-1VENTILATOR Eastern Anesthesia, Inc. | CBK |
| Oct 3, 1980 | K802118 | BEAR 2 ADULT VOL. VENTILATOR Bourns Medical Systems, Inc. | CBK |
| Oct 3, 1980 | K802087 | BABYBIRD 2 VENTILATOR Bird Products Corp. | CBK |
| Oct 3, 1980 | K802051 | NEWBOURNS INFANT VENTILATOR Bourns Medical Systems, Inc. | CBK |
| Aug 7, 1980 | K801697 | MODEL BP-200 INFANT PRESSURE VENTILATOR Bourns Medical Systems, Inc. | CBK |
| May 28, 1980 | K800999 | CAM-10 EXSUFFLATION BELT #11-001 Lifecare Services, Inc. | CBK |
| Apr 2, 1980 | K800650 | MOD. 300 ANESTH. VOL. VENTILATOR W/ALARM Hospal Medical Corp. | CBK |
| Mar 5, 1980 | K800114 | SIEMENS-ELEMA AB MANUAL VENTILATION Siemens Elema AB | CBK |
| Feb 5, 1980 | K792459 | PNEUPAC VENTILATOR/RESUSCITATOR Pneupac , Ltd. | CBK |
| Feb 5, 1980 | K792456 | PNEUPAC VENTILATOR/RESUSCITATOR #3 Pneupac , Ltd. | CBK |
| Feb 5, 1980 | K792455 | PNEUPAC VENTILATOR/RESUSCITATOR #2 Pneupac , Ltd. | CBK |
| Jan 24, 1980 | K800125 | VENTILATOR TEST LUNG Bio-Med Devices, Inc. | CBK |
| Dec 19, 1979 | K792564 | MA-1 VENTILATOR & TIMETER AIRCOMPRESSOR Eastern Anesthesia, Inc. | CBK |
| Sep 19, 1979 | K791713 | VICKERS MEDICAL MODEL 130 NEAVENT-NEO Vickers America Medical Corp. | CBK |
| Jul 6, 1979 | K791186 | MODEL BP-2000 TIME-CYCLED VENTILATOR Bourns Medical Systems, Inc. | CBK |
| Jul 5, 1979 | K791188 | CAM-10 BATTERY PACK (#7-001) Lifecare Services, Inc. | CBK |
| Jul 3, 1979 | K791033 | CAM-10 PVV PORTABLE VOLUME VENTILATOR Lifecare Services, Inc. | CBK |
| Jul 3, 1979 | K790605 | RESPIRAOTR, CAM-10 RBL Lifecare Services, Inc. | CBK |
| May 4, 1979 | K790809 | VS, ANESTHESIA VENTILATOR Airco/Ohio Medical Products | CBK |
| Apr 19, 1979 | K790733 | VENTIMETER VENTILATOR Narco Air-Shields | CBK |
| Apr 19, 1979 | K790732 | VENTIMETER CONTROLLER Narco Air-Shields | CBK |
| Apr 13, 1979 | K790199 | VENTILATOR MODEL BV-300 INFANT Bourns Medical Systems, Inc. | CBK |
| Dec 21, 1978 | K782074 | VENTILATOR, MODEL AVA-1, ADULT Rule Medical Instruments, Inc. | CBK |
| Dec 21, 1978 | K781926 | VENTILATOR, INFANT MODEL 100 Healthdyne, Inc. | CBK |
| Dec 13, 1978 | K781160 | VENTILATOR, MINILUNG Thompson Respiration Products, Inc. | CBK |
| Dec 12, 1978 | K781159 | VENTILATOR, PRESSURE Thompson Respiration Products, Inc. | CBK |
| Dec 11, 1978 | K781161 | RESPIRATOR, BANTAM MODEL Thompson Respiration Products, Inc. | CBK |
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