Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Puritan Bennett Corp. — Predicate Candidate Screening

110 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

77 daysmedian FDA review time

367 days90th percentile

110clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K063650	VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840	Puritan Bennett Corp.	2007-02-15	69	0
K053388	MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PL	Puritan Bennett Corp.	2006-04-04	120	1
K023225	PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE	Puritan Bennett Corp.	2002-12-18	82	0
K022103	PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM	Puritan Bennett Corp.	2002-09-27	91	0
K001646	PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION	Puritan Bennett Corp.	2000-10-20	143	1
K002001	BREEZE SLEEPGEAR WITH DREAMSEAL	Puritan Bennett Corp.	2000-09-06	68	0
K993071	PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE	Puritan Bennett Corp.	1999-11-24	71	1
K993220	PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM	Puritan Bennett Corp.	1999-10-22	25	0
K993088	PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI	Puritan Bennett Corp.	1999-10-08	22	0
K984535	PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION	Puritan Bennett Corp.	1998-12-28	7	1
K984379	NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM	Puritan Bennett Corp.	1998-12-10	3	4
K973004	KNIGHTSTAR 335	Puritan Bennett Corp.	1998-07-16	337	0
K970460	NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)	Puritan Bennett Corp.	1998-04-30	448	8
K964540	NELLCOR PURITAN BENNETT, 740 VENTILATOR SYSTEM	Puritan Bennett Corp.	1997-11-14	367	4
K963633	VENTNET; CENTRAL MONITORING STATION	Puritan Bennett Corp.	1996-12-16	96	0
K960518	THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM	Puritan Bennett Corp.	1996-05-09	94	0
K942210	PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM	Puritan Bennett Corp.	1996-02-09	647	0
K952292	PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM	Puritan Bennett Corp.	1995-11-13	181	0
K934804	PURITAN-BENNETT COMPANION 320 I/E	Puritan Bennett Corp.	1995-02-27	508	0
K944762	PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTION	Puritan Bennett Corp.	1994-12-13	77	0
K944347	PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)	Puritan Bennett Corp.	1994-12-12	97	0
K924978	7250 METABOLIC MONITOR	Puritan Bennett Corp.	1994-09-22	721	0
K922705	MODEL 7200AE VENTILATOR	Puritan Bennett Corp.	1994-09-22	839	0
K924043	AUTO-PEEP	Puritan Bennett Corp.	1994-09-22	772	0
K922975	MODEL 7200AE VENTILATOR (ENHANCEMENT)	Puritan Bennett Corp.	1994-09-22	822	0
K930017	PB 7200 SERIES VENTILATORY SYSTEM W/KEYBOARD	Puritan Bennett Corp.	1994-09-22	626	0
K922102	PROPORTIONAL SOLENOID VALVE	Puritan Bennett Corp.	1994-09-15	862	0
K936000	PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION	Puritan Bennett Corp.	1994-08-15	243	0
K933930	PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT	Puritan Bennett Corp.	1994-03-21	222	0
K931112	MODEL PB3300 INTRA-ARTER BLOOD GAS MONIT SYS, MODI	Puritan Bennett Corp.	1993-06-01	89	0
K923590	318A RESPIRATORY SUPPORT SYSTEM	Puritan Bennett Corp.	1993-04-09	263	0
K921809	COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)	Puritan Bennett Corp.	1992-12-04	233	0
K920002	MODEL 7200AE VENTILATOR FLOW BY 2.0 OR OPTION 50	Puritan Bennett Corp.	1992-11-10	313	0
K923809	PURITAN-BENNETT MODEL 7200AE VENTILATOR	Puritan Bennett Corp.	1992-10-27	90	0
K920783	OXYGEN FLOW CONTROLLER	Puritan Bennett Corp.	1992-09-18	211	0
K920338	COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR	Puritan Bennett Corp.	1992-08-27	216	0
K915312	MODIFICATION PURITAN BENETT COMPANION 2801 VOL VEN	Puritan Bennett Corp.	1992-07-08	229	0
K922178	COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION	Puritan Bennett Corp.	1992-05-29	21	0
K922004	MODIFICATION PURITAN-BENNETT INFANT PM2	Puritan Bennett Corp.	1992-05-28	29	0
K920570	PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED	Puritan Bennett Corp.	1992-02-27	20	0
K911143	PB100 DIAGNOSTIC SPIROMETER	Puritan Bennett Corp.	1991-11-29	260	0
K913370	MODIFICATION MANUAL RESUSCITATOR (PMR 2)	Puritan Bennett Corp.	1991-08-26	28	0
K911971	MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT.	Puritan Bennett Corp.	1991-08-09	98	0
K912428	PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT	Puritan Bennett Corp.	1991-08-09	70	0
K905397	PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM	Puritan Bennett Corp.	1991-05-14	165	0
K910194	COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM	Puritan Bennett Corp.	1991-05-13	117	0
K905530	PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM	Puritan Bennett Corp.	1991-03-01	81	0
K902506	7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD.	Puritan Bennett Corp.	1991-01-08	216	0
K903764	COMPANION 318 NASAL CPAP SYSTEM	Puritan Bennett Corp.	1990-09-10	21	0
K903140	PURITAN-BENNETT COMPAN EMT W/REMOTE LIQ LEV GUAGE	Puritan Bennett Corp.	1990-09-05	50	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda