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 |
|---|---|---|---|
| Oct 27, 1992 | K923809 | PURITAN-BENNETT MODEL 7200AE VENTILATOR Puritan Bennett Corp. | CBK |
| Oct 22, 1992 | K923704 | INFANT STAR SERIES 500 Infrasonics Corp. | CBK |
| Oct 22, 1992 | K915488 | PEDIATRIC VENTILATOR AND PARTNER VOLUME MONITOR Bird Products Corp. | CBK |
| Sep 10, 1992 | K914424 | MODEL 6213 REMOTE ALARM Aequitron Medical, Inc. | CBK |
| Aug 24, 1992 | K922477 | MODEL 105 VENTILATOR, MODIFICATION Infrasonics Corp. | CBK |
| Jul 8, 1992 | K915312 | MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN Puritan Bennett Corp. | CBK |
| Jun 11, 1992 | K912619 | BEAR 7 VENTILATOR Bear Medical Systems, Inc. | CBK |
| Jun 11, 1992 | K911804 | INFRASONICS VENTILATOR ADULT STAR, MODIFICATION Infrasonics Corp. | CBK |
| Apr 23, 1992 | K921726 | HAYEK OSCILLATOR, MODIFICATION Respironics, Inc. | CBK |
| Jan 30, 1992 | K913423 | LIFECARE REMOTE ALARM II Lifecare Services, Inc. | CBK |
| Jan 9, 1992 | K913972 | STAR SYNC, MODIFICATION Infrasonics Corp. | CBK |
| Dec 20, 1991 | K901448 | VEOLAR VENTILATOR Hamilton Medical, Inc. | CBK |
| Nov 29, 1991 | K911336 | BIRD NEBULIZATION SYNCHRONIZER Bird Products Corp. | CBK |
| Oct 25, 1991 | K914485 | VENTILATOR STAND Bird Products Corp. | CBK |
| Jul 25, 1991 | K912533 | NARKOMED AV-E VENTILATOR Draeger Medical, Inc. | CBK |
| Jun 18, 1991 | K911450 | INFANT VENTILATOR Preemicare Corp. | CBK |
| Jun 13, 1991 | K905234 | TXP TRANSPORTER FAMILY AND RELATED ACCESSORIES Percussionaire Corp. | CBK |
| Jun 10, 1991 | K903089 | BABYLOG 8000 INFANT VENTILATOR Drager, Inc. | CBK |
| May 3, 1991 | K910847 | OHMEDA 7810 ANESTHESIA VENTILATOR Ohmeda Medical | CBK |
| May 3, 1991 | K905235 | VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS Percussionaire Corp. | CBK |
| Apr 29, 1991 | K900745 | VS-200S JET VENTILATOR Acutronic Medical Systems AG, CH | CBK |
| Apr 29, 1991 | K900744 | AMS 3000 PORTABLE JET VENTILATOR Acutronic Medical Systems AG, CH | CBK |
| Apr 26, 1991 | K902859 | SERVO VENTILATOR 300 Siemens Life Support Systems | CBK |
| Mar 4, 1991 | K902405 | MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR Mallinckrodt Medical | CBK |
| Jan 30, 1991 | K905272 | ADULT STAR, MODIFICATION Infrasonics Corp. | CBK |
| Jan 8, 1991 | K902506 | 7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD. Puritan Bennett Corp. | CBK |
| Jan 2, 1991 | K901953 | AIROX AXR. 1A Ferguson Medical | CBK |
| Dec 19, 1990 | K895513 | PERRY SV-1 HYPERBARIC VENTILATOR Perry Baromedical Services | CBK |
| Nov 30, 1990 | K905244 | MODEL LP6 VENTILATOR, MODIFICATION Aequitron Medical, Inc. | CBK |
| Nov 30, 1990 | K903010 | CONTINUOUS VOLUME VENTILATOR MODEL LP10 Aequitron Medical, Inc. | CBK |
| Oct 26, 1990 | K900315 | PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN Percussionaire Corp. | CBK |
| Oct 26, 1990 | K900314 | PERCUSSIONAIRE(R) OSCILLATRON-1 PERCUSS 1300 MIN Percussionaire Corp. | CBK |
| Oct 26, 1990 | K900313 | PERCUSSIONAIRE(R) VDR-3 IMV PERCUS/RESPIR 1250 MIN Percussionaire Corp. | CBK |
| Oct 1, 1990 | K902084 | OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE Ohmeda Medical | CBK |
| Aug 10, 1990 | K901785 | NEWPORT WAVE VENTILATOR MODEL E200 Newport Medical Instruments, Inc. | CBK |
| Aug 3, 1990 | K900637 | BEAR CEM CONTROLLER Bear Medical Systems, Inc. | CBK |
| Jun 18, 1990 | K900465 | MAX TRANSPORT VENTILATOR Hamilton Medical, Inc. | CBK |
| May 18, 1990 | K896269 | SECHRIST VOLUME VENTILATOR MODEL 2200B Sechrist Industries, Inc. | CBK |
| Apr 16, 1990 | K896442 | PPG BIOMEDICAL VENTILATOR MODEL IRISA Ppg Industries, Inc. | CBK |
| Mar 26, 1990 | K897113 | PURITAN-BENNETT COMPANION 2801 VOLUME VENTILATOR Puritan Bennett Corp. | CBK |
| Mar 12, 1990 | K884389 | MODIFIED 225/SIMV VOLUME VENTILATOR Monaghan Medical Corp. | CBK |
| Mar 8, 1990 | K895541 | V.I.P. BIRD INFANT - PEDIATRIC VENTILATOR Bird Products Corp. | CBK |
| Feb 28, 1990 | K896736 | TYPE 9291 INTERFACE RESPIRATOR S & W Medico Teknik, DK | CBK |
| Feb 28, 1990 | K896735 | TYPE 9290 INTERFACE RESPIRATOR S & W Medico Teknik, DK | CBK |
| Feb 12, 1990 | K896381 | MVP-10 MRI INFANT VENTILATOR Bio-Med Devices, Inc. | CBK |
| Feb 12, 1990 | K896380 | IC-2A MRI ADULT/PEDIATRIC VENTILATOR Bio-Med Devices, Inc. | CBK |
| Jan 29, 1990 | K894322 | 8400ST VOLUME VENTILATOR Bird Products Corp. | CBK |
| Jan 3, 1990 | K893622 | PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL. Preemicare Corp. | CBK |
| Dec 7, 1989 | K895779 | MODIFIED PERMCATH TRAY (2ND SUBMISSION) Quinton, Inc. | CBK |
| Oct 27, 1989 | K892886 | PERCUSSIONAIRE OSCILLATRON-1 MEDICAL RESPIRATOR Percussionaire Corp. | CBK |
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