Company ยท US
Puritan Bennett Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2007. Name variants (Inc, Corp, punctuation) are merged.
114510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 35 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 13 |
| BZD | Ventilator, Non-Continuous (Respirator) | 8 |
| BYJ | Unit, Liquid-Oxygen, Portable | 7 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 6 |
| BZG | Spirometer, Diagnostic | 5 |
| CAW | Generator, Oxygen, Portable | 4 |
| CAN | Regulator, Pressure, Gas Cylinder | 3 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 3 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 |
| CBZ | Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling | 2 |
| DQA | Oximeter | 2 |
| MNT | Continuous, Minimal Ventilatory Support, Facility Use Ventilator | 2 |
| NFB | Conserver, Oxygen | 2 |
| BSZ | Gas-Machine, Anesthesia | 1 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 |
| BYG | Mask, Oxygen | 1 |
| BYT | Ventilator, External Body, Negative Pressure, Adult (Cuirass) | 1 |
| BZC | Calculator, Pulmonary Function Data | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 15, 2007 | K063650 | VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840 Puritan Bennett Corp. | CBK |
| Apr 4, 2006 | K053388 | MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION Puritan Bennett Corp. | CBK |
| Dec 18, 2002 | K023225 | PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE Puritan Bennett Corp. | BZG |
| Sep 27, 2002 | K022103 | PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM Puritan Bennett Corp. | BZG |
| Aug 13, 2002 | K021573 | PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION Puritan-Bennett | CBK |
| Oct 20, 2000 | K001646 | PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION Puritan Bennett Corp. | CBK |
| Sep 6, 2000 | K002001 | BREEZE SLEEPGEAR WITH DREAMSEAL Puritan Bennett Corp. | BZD |
| Nov 24, 1999 | K993071 | PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840 Puritan Bennett Corp. | CBK |
| Oct 22, 1999 | K993220 | PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM Puritan Bennett Corp. | BYJ |
| Oct 8, 1999 | K993088 | PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI Puritan Bennett Corp. | CAW |
| Dec 28, 1998 | K984535 | PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION Puritan Bennett Corp. | CBK |
| Dec 10, 1998 | K984379 | NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM Puritan Bennett Corp., IE | CBK |
| Jul 16, 1998 | K973004 | KNIGHTSTAR 335 Puritan Bennett Corp. | MNT |
| Apr 30, 1998 | K970460 | NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) Puritan Bennett Corp. | CBK |
| Nov 14, 1997 | K964540 | NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM Puritan Bennett Corp. | CBK |
| Dec 16, 1996 | K963633 | VENTNET; CENTRAL MONITORING STATION Puritan Bennett Corp. | MOD |
| May 9, 1996 | K960518 | THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM Puritan Bennett Corp. | BZD |
| Feb 9, 1996 | K942210 | PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM Puritan Bennett Corp. | MNS |
| Nov 13, 1995 | K952292 | PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM Puritan Bennett Corp. | BZD |
| Feb 27, 1995 | K934804 | PURITAN-BENNETT COMPANION 320 I/E Puritan Bennett Corp. | BZD |
| Dec 13, 1994 | K944762 | PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE Puritan Bennett Corp. | BZG |
| Dec 12, 1994 | K944347 | PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR) Puritan Bennett Corp. | BTM |
| Sep 22, 1994 | K930017 | PB 7200 SERIES VENTILATORY SYSTEM W/KEYBOARD Puritan Bennett Corp. | CBK |
| Sep 22, 1994 | K924978 | 7250 METABOLIC MONITOR Puritan Bennett Corp. | BZL |
| Sep 22, 1994 | K924043 | AUTO-PEEP Puritan Bennett Corp. | CBK |
| Sep 22, 1994 | K922975 | MODEL 7200AE VENTILATOR (ENHANCEMENT) Puritan Bennett Corp. | CBK |
| Sep 22, 1994 | K922705 | MODEL 7200AE VENTILATOR Puritan Bennett Corp. | CBK |
| Sep 15, 1994 | K922102 | PROPORTIONAL SOLENOID VALVE Puritan Bennett Corp. | CBK |
| Aug 15, 1994 | K936000 | PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION Puritan Bennett Corp. | BTT |
| Aug 11, 1994 | K943617 | DISPOSABLE MANUAL RESUSCITATOR Puritan-Bennett | BTM |
| Jul 13, 1994 | K935784 | PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM Puritan-Bennett | BZD |
| Jul 6, 1994 | K942246 | PURITAN-BENNETT NASAL CPAP MASK Puritan-Bennett | BYE |
| Mar 21, 1994 | K933930 | PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT Puritan Bennett Corp. | BYJ |
| Jun 1, 1993 | K931112 | MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI Puritan Bennett Corp. | CBZ |
| Apr 9, 1993 | K923590 | 318A RESPIRATORY SUPPORT SYSTEM Puritan Bennett Corp. | BZD |
| Dec 4, 1992 | K921809 | COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800) Puritan Bennett Corp. | CAF |
| Nov 10, 1992 | K920002 | MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50 Puritan Bennett Corp. | CBK |
| Oct 27, 1992 | K923809 | PURITAN-BENNETT MODEL 7200AE VENTILATOR Puritan Bennett Corp. | CBK |
| Sep 18, 1992 | K920783 | OXYGEN FLOW CONTROLLER Puritan Bennett Corp. | CCN |
| Aug 27, 1992 | K920338 | COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR Puritan Bennett Corp. | CCL |
| Jul 8, 1992 | K915312 | MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN Puritan Bennett Corp. | CBK |
| May 29, 1992 | K922178 | COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION Puritan Bennett Corp. | BYE |
| May 28, 1992 | K922004 | MODIFICATION PURITAN-BENNETT INFANT PM2 Puritan Bennett Corp. | BTM |
| Feb 27, 1992 | K920570 | PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED Puritan Bennett Corp. | BTM |
| Nov 29, 1991 | K911143 | PB100 DIAGNOSTIC SPIROMETER Puritan Bennett Corp. | BZM |
| Aug 26, 1991 | K913370 | MODIFICATION MANUAL RESUSCITATOR (PMR 2) Puritan Bennett Corp. | BTM |
| Aug 9, 1991 | K912428 | PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT Puritan Bennett Corp. | CBZ |
| Aug 9, 1991 | K911971 | MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT. Puritan Bennett Corp. | BTM |
| May 14, 1991 | K905397 | PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM Puritan Bennett Corp. | CCE |
| May 13, 1991 | K910194 | COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM Puritan Bennett Corp. | BZD |
Newest 50 of 114.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 9, 2007 | Puritan Bennett Corporation Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD Terminated |
MNT | K003075 |
| Aug 6, 2005 | Puritan Bennett Puritan Bennett 840 Series Ventilator Power Supply
Model/Catalog Numbers: 4-076314-00; 4-076314-SP Terminated |
CBK | K970460 |