Product Code: CAX FDA class 1 21 CFR 868.2340

Flowmeter, Tube, Thorpe, Back-Pressure Compensated

Anesthesiology

The Back-Pressure Compensated Thorpe Tube Flowmeter is an anesthesiology device used to measure and control the flow rate of medical gases such as oxygen or nitrous oxide delivered to patients, with compensation mechanisms that maintain accuracy regardless of downstream pressure changes. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CAX, regulated under 21 CFR 868.2340, within the Anesthesiology medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: CAX
Device Class: FDA class 1
Regulation Number: 868.2340
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

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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 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K923781	MXR-2000 FLOWMETER	Jun 10, 1993	Substantially Equivalent	Porter Instrument Co., Inc.
K910316	OHMEDA - LOW FLOW FLOWMETER	Apr 12, 1991	Substantially Equivalent	Ohmeda Medical
K884973	FR6000 FLOWMETER	Jan 17, 1989	Substantially Equivalent	Key Instruments
K872718	SERIES D FLOWMETER	Aug 05, 1987	Substantially Equivalent	Puritan Bennett Corp.
K871452	CLASSIC (TM) 200 OXYGEN FLOWMETER	Jun 22, 1987	Substantially Equivalent	The Timeter Group
K862797	AIRCO 2000 SERIES FLOWMETERS	Aug 08, 1986	Substantially Equivalent	Airco, Inc.
K854067	SELECT FLOWMETER	Oct 29, 1985	Substantially Equivalent	Precision Medical, Inc.
K851288	OXYGEN DELIVERY MEASURING DEVICE	Sep 03, 1985	Substantially Equivalent	Bar-Dix, Inc.
K850559	PRESSURE RELIEF ADAPTOR	Apr 25, 1985	Substantially Equivalent	Precision Medical, Inc.
K850560	FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE	Apr 17, 1985	Substantially Equivalent	Precision Medical, Inc.
K834260	RECON-2 FLOW CONTROLLER	Jan 10, 1984	Substantially Equivalent	Precision Metering, Inc.
K812419	PRESET FLOWMETER	Sep 21, 1981	Substantially Equivalent	Timeter Instrument Corp.
K812183	TIMETER-PRODUCED PURITAN BENNETT AIR ADP	Aug 18, 1981	Substantially Equivalent	Timeter Instrument Corp.
K812128	RECON 1	Aug 18, 1981	Substantially Equivalent	Precision Metering, Inc.
K802659	RESPIRATORY THERAPY FLOWMETER	Nov 12, 1980	Substantially Equivalent	Design & Manufacturing Consultants
K802311	MO8 OXYGEN FLOWMETER	Oct 23, 1980	Substantially Equivalent	Timeter Instrument Corp.
K791900	M015 OXYGEN & MA15 AIR	Oct 11, 1979	Substantially Equivalent	Timeter Instrument Corp.
K791648	MODEL 54 FLOWMETER BACK-PRESSURE TUBE	Sep 17, 1979	Substantially Equivalent	Harris Calorific
K791220	FLOWMETER, BACK PRESSURE COMPENSATED,	Aug 03, 1979	Substantially Equivalent	Timeter Instrument Corp.
K791017	FLOW LIMITER	Jul 03, 1979	Substantially Equivalent	Timeter Instrument Corp.
K791069	LINDE OXYGEN THERAPY FLOWMETERS, L33-L34	Jun 27, 1979	Substantially Equivalent	Union Carbide Corp.
K781541	FLOMETER	Sep 26, 1978	Substantially Equivalent	Chemetron Medical Products, Inc.
K760314	FLOWMETER, OXYGEN	Aug 04, 1976	Substantially Equivalent	Harris-Lake, Inc.
K760102	FLOWMETER, P.C., REDESIGNED VERSION	Jul 16, 1976	Substantially Equivalent	Ohio Medical Products