Product Code: CAT FDA class 1 21 CFR 868.5340

Cannula, Nasal, Oxygen

Anesthesiology

The Nasal Oxygen Cannula is a simple anesthesiology device consisting of a lightweight tube with two prongs that rest inside the nostrils, used to deliver supplemental oxygen to patients requiring low-flow oxygen therapy. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CAT, regulated under 21 CFR 868.5340, within the Anesthesiology medical specialty. No special flags apply to this device.

View on FDA

510(k)s

FEI Numbers

263

Registration Numbers

263

Unique Applicants

Years Active

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Basic Information

Product Code: CAT
Device Class: FDA class 1
Regulation Number: 868.5340
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 42 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K011125	NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI	Jun 13, 2001	Substantially Equivalent	Hudson Respiratory Care, Inc.
K935533	NASAL CANNULA	Feb 03, 1994	Substantially Equivalent	Puritas Health Care, Inc.
K922397	4 SURE TM NASAL OXYGEN CANNULA	Mar 18, 1993	Substantially Equivalent	Boston Pacific Medical, Inc.
K921496	SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED	Aug 14, 1992	Substantially Equivalent	Alpine Specialties, Inc.
K920573	CANNULA NASAL OXYGEN	Aug 11, 1992	Substantially Equivalent	B & F Medical Products, Inc.
K913421	NASAL OXYGEN CANNULA, 81585, 81587 & 81589	Oct 18, 1991	Substantially Equivalent	Specialty Packaging Producs, Inc.
K912197	SKIN SAVER(TM) TUBING HOLDER, MODEL 467	Aug 20, 1991	Substantially Equivalent	Alpine Specialties, Inc.
K911740	SALTER LABS NEONATAL NASAL OXYGEN CANNULA	Jul 24, 1991	Substantially Equivalent	Salter Labs
K902420	CATHETER, NASAL, OXYGEN	Apr 17, 1991	Substantially Equivalent	Gainor Medical Europe, Ltd.
K896036	THE COMFORTABLE CANNULA	Nov 17, 1989	Substantially Equivalent	Comfortable Concepts Corp.
K892435	KENDALL CURITY OXYGEN NASAL CANNULA	Jun 12, 1989	Substantially Equivalent	The Kendal Co.
K884149	COMFORT STRAP	Oct 21, 1988	Substantially Equivalent	Comfort Strap Co.
K863432	OXYGEN CANNULA EAR WRAP (STYLE B)	Sep 18, 1986	Substantially Equivalent	Salter Labs
K863431	OXYGEN CANNULA EAR WRAP (STYLE A)	Sep 18, 1986	Substantially Equivalent	Salter Labs
K860535	UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS)	Apr 01, 1986	Substantially Equivalent	Andover Medical, Inc.
K860872	NASAL CANNULA W/2M & 5M TUBING	Mar 19, 1986	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K860261	CANNULA BAND	Feb 18, 1986	Substantially Equivalent	T. G. & E. Medical
K852628	NASAL ONE	Sep 18, 1985	Substantially Equivalent	Ashai Co. , Ltd.
K852625	OXY-TUBE	Sep 18, 1985	Substantially Equivalent	Ashai Co. , Ltd.
K850066	OMNIMED NASAL OXYGEN CANNULA	Jan 24, 1985	Substantially Equivalent	Omni Intl., Inc.
K843467	PHARMA-PLAST NASAL OXYGEN CANNULA	Nov 19, 1984	Substantially Equivalent	Zimmar Consulting , Ltd.
K844084	POLYVINYL CHLORIDE CANNULAS	Oct 30, 1984	Substantially Equivalent	Hudson Extrusions, Inc.
K844083	STRAIGHT AND BUBBLE OXYGEN TUBING	Oct 30, 1984	Substantially Equivalent	Hudson Extrusions, Inc.
K842968	CHAD ADJUSTABLE CANNULA	Aug 29, 1984	Substantially Equivalent	Chad Therapeutics, Inc.
K840897	OXYGEN TUBING	Mar 16, 1984	Substantially Equivalent	Medical Technologies of Georgia
K833127	ARGYLE NASAL CANNULA	Nov 03, 1983	Substantially Equivalent	Sherwood Medical Co.
K823506	NASAL CANNULA	Dec 09, 1982	Substantially Equivalent	Seven Harvest Intl. Import & Export
K811789	OECO NASAL CANNULA	Jul 02, 1981	Substantially Equivalent	Oeco
K810342	NASAL CANNULA	Mar 17, 1981	Substantially Equivalent	Todd Industries, Inc.
K802062	SOF-TOUCH NASAL CANNULA CAT.#304 & 305	Sep 09, 1980	Substantially Equivalent	Hospitak, Inc.
K791247	CONPHAR NASAL OXYGEN CANNULA-STERILE	Jul 24, 1979	Substantially Equivalent	Conphar, Inc.
K790885	NASAL, OXYGEN, CANNULA	May 17, 1979	Substantially Equivalent	Airlife, Inc.
K790056	CANNULAS, DYNACOR'S NASAL OXYGEN	Feb 05, 1979	Substantially Equivalent	Medline Industries, Inc.
K781415	CANNULA, NASAL, OXYGEN	Sep 07, 1978	Substantially Equivalent	Vitalab Products Corp.
K771074	NASAL OXYGEN CANNULA, #017207	Aug 04, 1977	Substantially Equivalent	C.R. Bard, Inc.
K770996	OXYGEN CANNULA	Jun 29, 1977	Substantially Equivalent	Ohio Medical Products
K770487	LIGHTWEIGHT PLASTIC CANNULA	Mar 21, 1977	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K760551	CANNULA, LARRIAT	Sep 05, 1976	Substantially Equivalent	Landmark Plastics
K760337	CANNULA, ARGYLE NASAL OXYGEN	Aug 11, 1976	Substantially Equivalent	Sherwood Medical Industries
K760330	CANNULA, DISPOSABLE OXYGEN TTHERAPY	Aug 04, 1976	Substantially Equivalent	Inhal-O-Tech Medical Plastic
K760218	CANNULAE, PLASTIC DISPOSABLE NASAL	Aug 03, 1976	Substantially Equivalent	Manner Medical Products
K760080	CANNULA, NASAL, FOR OXYGEN	Jul 15, 1976	Substantially Equivalent	Inspiron Corp.