Product Code: CAN FDA class 1 21 CFR 868.2700

Regulator, Pressure, Gas Cylinder

Anesthesiology

The Gas Cylinder Pressure Regulator is an anesthesiology device that reduces and controls the high-pressure gas output from a compressed gas cylinder to a safe, usable working pressure for delivery to anesthesia or respiratory equipment. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CAN, regulated under 21 CFR 868.2700, within the Anesthesiology medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

111

Registration Numbers

112

Unique Applicants

Years Active

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Basic Information

Product Code: CAN
Device Class: FDA class 1
Regulation Number: 868.2700
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 55 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K162811	MR Conditional CGA 870	Mar 02, 2017	Substantially Equivalent	Essex Industries, Inc.
K080243	PORTABLE OXYGEN UNIT SCA900	Apr 07, 2009	Substantially Equivalent	San Cheong Co. , Ltd.
K060265	REMCORE REMOTE CONTROLLED OXYGEN REGULATOR	Oct 25, 2006	Substantially Equivalent	Remcore, Inc.
K061785	CYL-FIL OXYGEN SYSTEM	Sep 07, 2006	Substantially Equivalent	Responsive Respiratory, Inc.
K950777	OXYGEN REGULATOR	Apr 14, 1995	Substantially Equivalent	Mada Medical Products, Inc.
K942751	VANGUARD SERIES GAS REGULATORS	Feb 09, 1995	Substantially Equivalent	Buckman Co., Inc.
K936187	LSPI PRESSURE REGULATOR	Jan 27, 1994	Substantially Equivalent	Life Support Products, Inc.
K932006	1500 SERIES REGULATOR	Oct 25, 1993	Substantially Equivalent	Precision Medical, Inc.
K921125	AMBU OXYGEN REGULATOR	Sep 17, 1992	Substantially Equivalent	Amg, LLC
K915154	GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS	May 27, 1992	Substantially Equivalent	C.G.H. Medical, Inc.
K915505	REGULATOR FLOWMETER	Apr 22, 1992	Substantially Equivalent	Lifeguard Medical Products, Inc.
K914271	GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)	Apr 13, 1992	Substantially Equivalent	C.G.H. Medical, Inc.
K912174	SALTER LABS DISPOSABLE NIPPLE AND NUT	Jul 24, 1991	Substantially Equivalent	Salter Labs
K901831	PRECISION MEDICAL OXYGEN REGULATOR	Aug 14, 1990	Substantially Equivalent	Precision Medical, Inc.
K901623	AMBU OXYGEN REGULATOR	Apr 26, 1990	Substantially Equivalent	Flotec, Inc.
K895956	RX02 EMERGENCY MEDICAL OXYGEN	Apr 05, 1990	Substantially Equivalent	Progressive Medical Applications Corp.
K900115	VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B	Feb 22, 1990	Substantially Equivalent	Ventlab Corp.
K896152	PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.	Jan 09, 1990	Substantially Equivalent	Puritan Bennett Corp.
K896128	PURITAN-BENNETT OXYGEN PRESSURE REGULATOR	Jan 09, 1990	Substantially Equivalent	Puritan Bennett Corp.
K894850	8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI	Aug 31, 1989	Substantially Equivalent	Modern Engineering Co., Inc.
K894302	OXYGEN THERAPY REGULATOR	Aug 07, 1989	Substantially Equivalent	Modern Engineering Co., Inc.
K893621	CONCOA PRESSURE REGULATORS	Jul 28, 1989	Substantially Equivalent	Concoa Controls Corp. of America
K891771	VICTOR MEDICAL OXYGEN THERAPY REGULATOR, MODIFIED	Jun 23, 1989	Substantially Equivalent	Thermadyne Holings Corp.
K884927	BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER	Jun 23, 1989	Substantially Equivalent	Instrumentation Industries, Inc.
K883483	AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATOR	Oct 07, 1988	Substantially Equivalent	Autoflow Products, Co.
K872170	CRT PORTABLE EMERGENCY OXYGEN INHALATOR	Sep 03, 1987	Substantially Equivalent	Cost Reduction Technologies, Inc.
K865077	ACCU-FLO REGULATOR	Feb 10, 1987	Substantially Equivalent	Alum-Ox, Inc.
K863711	REGULATOR OXYGEN MECHANICAL	Jan 27, 1987	Substantially Equivalent	Lifeguard Medical Products, Inc.
K862796	AIRCO PRESSURE REGULATORS	Aug 08, 1986	Substantially Equivalent	Airco, Inc.
K862193	# 10099/10225/10235/10275/10525/10625/10715/10125	Jul 09, 1986	Substantially Equivalent	U.O. Equipment Co.
K853039	PRESSURE REGULATOR	Apr 11, 1986	Substantially Equivalent	Erie Medical
K861166	OXYGEN THERAPY REGULATOR OR REGULATOR-FLOWMETER	Apr 01, 1986	Substantially Equivalent	Victor
K852333	DOWNS VPAP CIRCUIT	Oct 16, 1985	Substantially Equivalent	Vital Signs, Inc.
K852663	PORTABLE GASEOUS OXGYEN CONTAINER	Aug 29, 1985	Substantially Equivalent	Cryogenic Assoc.
K852649	PRESSURE REGULATOR/Y CONNECTOR	Aug 02, 1985	Substantially Equivalent	C.R. Bard, Inc.
K852374	OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT18	Jul 12, 1985	Substantially Equivalent	The Timeter Group
K844622	SAV-A-LIFE	Feb 26, 1985	Substantially Equivalent	Southern Medical Products, Inc.
K850106	AIRCO NITROUS OXIDE REGULATOR	Jan 24, 1985	Substantially Equivalent	Airco, Inc.
K843585	BEMCO PORTABLE OXYGEN INHALATOR	Oct 12, 1984	Substantially Equivalent	Bemco, Inc.
K841367	AIRCO OXYGEN REGULATOR	Apr 13, 1984	Substantially Equivalent	Welding Products
K834061	SLO-FLO 40AL ADJUST-FLOW REGULATOR	Jan 10, 1984	Substantially Equivalent	S.L.O. Health Products, Inc.
K830844	PORTABLE OXYGEN SYSTEM	May 27, 1983	Substantially Equivalent	Puritan Bennett Corp.
K813467	2002 ADJUSTABLE FLOW REGULATOR	Jan 07, 1982	Substantially Equivalent	Safety Laboratories West
K813466	4004 CONSTANT FLOW REGULATOR	Jan 07, 1982	Substantially Equivalent	Safety Laboratories West
K811430	ANESTHESIOLOGY DEVICE	Jun 09, 1981	Substantially Equivalent	Vital Air Oxygen Co.
K810679	MS-303-OXYGEN REGULATOR SHIELD	Apr 17, 1981	Substantially Equivalent	Instrumentation Industries, Inc.
K810132	MODEL 2 FLOWMETER	Jan 28, 1981	Substantially Equivalent	Harris Calorific
K803207	REGULATOR, OXYGEN MECHANICAL	Jan 15, 1981	Substantially Equivalent	Timeter Instrument Corp.
K802644	EMERG. OXYGEN KIT #65350 & #65399 CASE	Dec 22, 1980	Substantially Equivalent	B & F Medical Products, Inc.
K780750	O2 CONNECTOR	Jul 27, 1978	Substantially Equivalent	Diemolding Corp.
K780359	OXYGEN REGULATOR/FLOWMETER	Apr 04, 1978	Substantially Equivalent	Erie Mfg., Co.
K780364	MANIFOLD KIT	Mar 30, 1978	Substantially Equivalent	Spica, Inc.
K780084	OXYGEN THERAPY KIT	Jan 30, 1978	Substantially Equivalent	Thermadyne Holings Corp.
K772216	PORT-A-BOUT 240	Jan 05, 1978	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K771241	SPIR-E-VAC	Sep 15, 1977	Substantially Equivalent	Breathing Services, Inc.