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

CAD · Predicate Candidate Screening

57 FDA 510(k) clearances under this product code; the 50 most recent screened below.

86 daysmedian FDA review time

302 days90th percentile

57clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K240375	V80 Anesthetic Vaporizer (V80)	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2024-10-31	267	0
K172702	Tec 820, Tec 850	Datex-Ohmeda, Inc.	2018-01-04	119	4
K150167	V60 Anesthetic Vaporizer	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2015-06-30	155	0
K110608	SEVOFLURANE VAPORIZER ADAPTOR	Piramal Critcal Care, Inc (Formerly Minrad, Inc)	2011-07-20	139	0
K060331	SIGMA ALPHA VAPORIZER	Penlon Limited	2006-05-10	90	0
K053564	KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 534	Penlon Limited	2006-03-03	71	0
K051666	GAV - GENERAL ANAESTHETIC VAPORIZER	General Anaesthetic Services Limited	2005-08-23	62	0
K042276	D-VAPOR	Draeger Medical, Inc.	2004-09-23	31	0
K041076	DELTA T	Penlon , Ltd.	2004-08-09	105	0
K031027	DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)	Datex-Ohmeda, Inc.	2003-06-26	86	0
K012924	DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER	Datex-Ohmeda, Inc.	2002-01-30	152	0
K002343	SIGMA DELTA	Penlon , Ltd.	2001-06-08	311	1
K002878	DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER	Datex-Ohmeda, Inc.	2000-09-21	6	0
K000275	DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA T	Datex-Ohmeda, Inc.	2000-04-12	72	3
K990132	DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC	Datex-Ohmeda, Inc.	1999-01-21	7	0
K980489	VAPAMASTA 6	Medical Industrial Equipment	1998-08-31	203	0
K980884	SIEMENS SEVOFLURANE VAPORIZER SV 953	Siemens Medical Solutions USA, Inc.	1998-08-19	163	0
K981773	DRAGER-VAPOR 19.3	Draeger Medical, Inc.	1998-07-06	47	0
K981472	DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS	Draeger Medical, Inc.	1998-05-07	13	0
K973051	DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS	Draeger Medical, Inc.	1997-10-30	76	0
K971923	DRAGER-VAPOR 2000	Draeger Medical, Inc.	1997-09-16	116	2
K952083	TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE	Clover Medical Equipment Services, Inc.	1996-10-21	537	0
K961468	QUIK-FIL VAPORIZER KEYED FILLER	Penlon , Ltd.	1996-07-16	90	0
K960944	PPV VAPORIZER (MODIFICATION)	Penlon , Ltd.	1996-04-02	49	0
K953748	TECHNOFIL	Technimeca Medic, Inc.	1996-01-25	167	0
K954801	TECHFIL	Technimeca Medic, Inc.	1996-01-25	98	0
K942799	DATUM	Blease USA, Inc.	1995-04-13	302	0
K942091	OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE	Ohmeda Medical	1995-03-30	332	0
K945993	VAPOFIL	Southmedic, Inc.	1995-02-22	96	2
K942545	SIGMA ELITE	Penlon , Ltd.	1995-02-03	248	0
K942055	DRAGER-VAPOR 19.1	North American Grager	1995-01-27	274	0
K936046	SIGMA ELITE	Penlon, Inc.	1994-11-04	319	0
K923265	FUNNEL ADAPTOR	Southmedic, Inc.	1993-03-18	259	0
K913593	OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER	Ohmeda Medical	1992-10-06	420	0
K892057	OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER	Ohmeda Medical	1989-04-26	28	0
K884686	VAPAMASTA 5	Dentsply Intl.	1989-03-15	127	0
K884090	LUNDY VAPORIZER SYSTEM	Vaporflow Technology, Inc.	1989-01-24	118	0
K882500	VAPORIZER, ANESTHESIA, NON-HEATED	Anesthetic Vaporizer Services	1988-08-01	45	0
K872053	KEYFILL	Mayfield Instruments, Ltd.	1987-07-01	30	0
K864605	VAPLOK	Bear Medical Systems, Inc.	1987-02-03	71	0
K861839	VAPOFIL	Southmedic, Inc.	1986-05-21	8	0
K860545	VAPORIZER SPACER	Southmedic, Inc.	1986-04-17	63	0
K854202	ANESTHESIA VENTILATOR MODEL 100	Rusz Instruments, Inc.	1986-04-11	178	0
K844007	PENLON PPV VAPORIZER	Penlon, Inc.	1985-03-12	151	0
K843993	ANAESLOCK THREE VAPORIZER INTERLOCK HVA003	Southmedic, Inc.	1984-11-15	35	0
K841157	HALOTHANE VAPORIZER 950, ENFLURANE	Siemens Elema AB	1984-06-07	80	0
K831427	CYPRANE TEC 4 CONTINUOUS FLOW VAPOR.	Fraser Harlake, Inc.	1983-07-07	65	0
K821966	MODULUS VERNI-TROL ANESTHETIC VAPORIZER	Ohio Medical Products	1982-07-16	14	0
K821650	DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS	Draeger Medical, Inc.	1982-06-29	25	0
K810289	MODULUS VERNI-TROL ANESTHETIC VAPORIZER	Ohio Medical Products	1981-03-04	30	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