Product Code: CBN FDA class 2 21 CFR 868.5430

Apparatus, Gas-Scavenging

Anesthesiology

The Gas-Scavenging Apparatus is an anesthesiology device used to capture and safely dispose of waste anesthetic gases that escape from the patient breathing circuit, protecting operating room personnel from chronic exposure to potentially harmful volatile agents. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CBN, regulated under 21 CFR 868.5430, within the Anesthesiology medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: CBN
Device Class: FDA class 2
Regulation Number: 868.5430
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 43 510(k) clearances via K numbers.

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