Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

CBN — Predicate Candidate Screening

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

87 daysmedian FDA review time

340 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K223452	Nitronox Scavenger Plus	Parker Hannifin Corporation	2023-03-05	110	0
K193646	Dynamic Gas Scavenging System 2 (DGSS - 2)	Anesthetic Gas Reclamation, Inc.	2020-12-04	340	0
K160950	MINISCAV	Sedation Systems, LLC	2017-05-05	395	1
K142138	ISO-GARD MASK	Teleflexmedical, Inc.	2014-10-30	86	0
K132729	ISO-GARD MASK	Teleflexmedical, Inc.	2014-01-09	128	0
K123176	ISO-GARD CLEARAIR MASK	Teleflexmedical, Inc.	2013-02-14	127	0
K110930	ACTIVE WASTE GAS SCAVENGER	G. Dundas Co.,Inc.	2011-06-23	80	0
K092031	VAPOR-CLEAR, MODEL 100	Axon Medical, Inc.	2010-04-16	284	1
K080039	PASSIVE WASTE GAS SCAVENGER, MODEL 14600	G. Dundas Co.,Inc.	2008-04-14	98	0
K072255	MINRAD INC. NASAL SCAVENGING CIRCUIT	Minrad, Inc.	2007-10-18	66	0
K063519	DYNAMIC GAS SCAVENGING SYSTEM (DGSS)	Anesthetic Gas Reclamation, LLC	2006-12-01	10	0
K033028	ANEFIN, MODEL 100	Axon Medical	2005-07-22	665	0
K033503	RFS VACUUM GAUGE SCAVENGING CIRCUIT	Accutron, Inc.	2004-03-12	128	0
K981754	AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000	Porter Instrument Co., Inc.	1998-06-16	29	0
K963601	MODEL 1920 WASTE GAS SCAVENGER	G. Dundas Co.	1997-04-28	231	0
K965239	PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW	Accutron, Inc.	1997-03-28	87	0
K953269	SAFECIRCUIT MANIFOLD/PULMONARY UNIT	Advanced Warming Systems, Inc.	1996-12-20	526	0
K945216	AES, (ANESCO EVACUATION SYSTEM) ACTIVE WASTE ANESTHETIC GAS	Anesco	1995-09-15	325	0
K920043	AIRES	Viva-Tek Assoc., Inc.	1993-06-16	527	0
K915287	ISOL-AIDE	Computronic Systems	1992-10-16	330	0
K921313	AEROSTAR	Biosafety Systems, Inc.	1992-09-11	177	0
K904803	CAP-EVAC ADAPTER	Logan, Inc.	1990-11-05	12	0
K902161	DEMISTIFIER ISOLATION CHAMBER	Peace Medical, Inc.	1990-10-15	153	0
K896510	TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.	Technical Medical Products, Inc.	1990-01-22	69	0
K893532	RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963	Medipart Jerry Alexander	1989-08-21	105	0
K890438	GAS-VAK(R), MODEL 300	Gas-Vak	1989-08-07	188	0
K884167	TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.	Technical Medical Products, Inc.	1988-10-28	24	0
K864034	OPEN RESERVOIR SCAVENGER	Draeger Medical, Inc.	1986-12-15	61	0
K854571	DEMAND FLOW VALVE & SONRA W/NASAL MASK	Gale E. Dryden	1986-02-10	88	0
K852772	GAS EVACUATION ACCESSORY	Siemens Elema AB	1985-10-10	105	0
K841733	OHIO WASTE GAS SCAVENGING RESERVOIR	Ohio Medical Products	1984-07-11	76	0
K841507	FOSTER 757 SCAVENGER	Colson Equipment, Inc.	1984-06-14	64	0
K842003	OHIO WASTE GAS SCAVENGING INTERFACE	Ohio Medical Products	1984-05-23	7	0
K840849	SCAVENGER TUBING 19MM	The Kendal Co.	1984-03-12	17	0
K832752	COMFORT CUSHION DISPOS. ANALGESIS	Mission Dental, Inc.	1983-12-08	115	0
K833692	FRASER HARLAKE DENTAL ANTI-POLUTION SYS	Fraser Harlake, Inc.	1983-11-29	42	0
K821744	FRASER HARLAKE NITRONOX SCAVENGER	Fraser Harlake, Inc.	1982-06-25	11	0
K802067	CLEAN-AIR POLLUTION REDUCTION SYSTEM	Porter Instrument Co., Inc.	1980-09-26	30	0
K791127	POSIVAC	Vital Signs, Inc.	1979-07-30	42	0
K790333	NAD SCAVENGING RELIEF VALVE	Draeger Medical, Inc.	1979-03-22	34	0
K770344	SH-1	Delta Medical Industries	1977-05-09	80	0
K761196	NITROUS OXIDE SCAVENGING MASK	Mckesson Corp.	1976-12-13	7	0
K761140	FRASER SWEATMAN'S DOUBLE MASK	Fraser Sweatman, Inc.	1976-12-09	13	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