Product Code: BYX FDA class 1 21 CFR 868.5860

Tubing, Pressure And Accessories

Anesthesiology

The Tubing, Pressure and Accessories consists of flexible pressure tubing and associated fittings used to connect components of anesthesia and respiratory systems, conveying gases or monitoring pressure signals within medical gas circuits. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BYX, regulated under 21 CFR 868.5860 in the Anesthesiology specialty.

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510(k)s

FEI Numbers

230

Registration Numbers

230

Unique Applicants

Years Active

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Basic Information

Product Code: BYX
Device Class: FDA class 1
Regulation Number: 868.5860
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 62 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K011134	OXYGEN SUPPLY TUBING, MODEL 1115	Jun 13, 2001	Substantially Equivalent	Hudson Respiratory Care, Inc.
K955656	NORTH STATE PLASTICS AEROSOL TEE	Mar 06, 1996	Substantially Equivalent	North State Plastics, Inc.
K943110	GAS SAMPLING INTERFACES	Aug 19, 1994	Substantially Equivalent	Coast Medical, Inc.
K935835	BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES	Jan 12, 1994	Substantially Equivalent	Busse Hospital Disposables, Inc.
K931043	MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS	Jun 01, 1993	Substantially Equivalent	Medical Fittings, Inc.
K931033	MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS	Jun 01, 1993	Substantially Equivalent	Medical Fittings, Inc.
K913422	OXYGEN TUBING, 81503	Jan 30, 1992	Substantially Equivalent	Specialty Packaging Producs, Inc.
K914980	HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES	Jan 21, 1992	Substantially Equivalent	Medical Fittings, Inc.
K912763	OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS)	Oct 15, 1991	Substantially Equivalent	Medical Fittings, Inc.
K905091	VARIOUS MALE QUICK CONNECTS.	Mar 04, 1991	Substantially Equivalent	Medical Fittings, Inc.
K905094	SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN	Nov 20, 1990	Substantially Equivalent	Medical Fittings, Inc.
K904757	OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERS	Oct 31, 1990	Substantially Equivalent	Medical Fittings, Inc.
K904702	MEDI FITT/OXEQUIP OXYGEN/AIR MALE QUICK CONNECTS	Oct 31, 1990	Substantially Equivalent	Medical Fittings, Inc.
K904701	MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN	Oct 31, 1990	Substantially Equivalent	Medical Fittings, Inc.
K904337	OXYGEN, AIR, VACUUM AND NITROUS-OXIDE MALE CONN.	Oct 04, 1990	Substantially Equivalent	Medical Fittings, Inc.
K901983	OXYGEN, AIR & VACUUM COUPLER & NITROUS-OXIDE COUP.	Aug 14, 1990	Substantially Equivalent	Medical Fittings, Inc.
K901961	OXYGEN COUPLER, AIR COUPLER & VACUUM COUPLER	Aug 14, 1990	Substantially Equivalent	Medical Fittings, Inc.
K863912	THE MMG 5 IN 1 CONNECTOR	Oct 27, 1986	Substantially Equivalent	Medical Marketing Group
K860877	FLEXTUBE, CONNECTING TUBING	Mar 20, 1986	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K854239	OXYCOIL	Nov 14, 1985	Substantially Equivalent	Chad Therapeutics, Inc.
K853569	MEDIPART CORRUGATED POLYETHYLENE & E.V.A. TUBING	Nov 07, 1985	Substantially Equivalent	Medipart Jerry Alexander
K852081	PENNINE OXYGEN LINK TUBING	Jun 14, 1985	Substantially Equivalent	Pennine Medical , Ltd.
K841901	OXYMIZER FLOW RESTRICTOR	Jul 23, 1984	Substantially Equivalent	Chad Therapeutics, Inc.
K840790	UNIVERSAL OXYGEN TUBING CONNECTOR	Mar 30, 1984	Substantially Equivalent	Cherry Plastics, Inc.
K832660	OXYGEN CONNECTING TUBESET-RESPIRATORY	Sep 26, 1983	Substantially Equivalent	San Diego Plastics, Inc.
K831146	OXYCOIL	May 16, 1983	Substantially Equivalent	Channing Corp.
K831082	CONNECTING TUBING	May 09, 1983	Substantially Equivalent	The Kendall Company Div. of Tyco Healthcare Group
K830988	OXYGEN CONNECTING TUBE	May 03, 1983	Substantially Equivalent	Medovations, Inc.
K823246	AUSTIN INHALATOR	Dec 16, 1982	Substantially Equivalent	Ems Industries, Inc.
K823142	OXYGEN TUBINGS	Nov 29, 1982	Substantially Equivalent	Seven Harvest Intl. Import & Export
K813074	CONNECTORS & ADAPTERS	Dec 31, 1981	Substantially Equivalent	Seven Harvest Intl. Import & Export
K813197	OXYGEN CONNECTING TUBE	Dec 18, 1981	Substantially Equivalent	Northern Medical Industries
K813234	OHIO AIR ADAPTOR	Dec 08, 1981	Substantially Equivalent	Timeter Instrument Corp.
K811551	TIMETER PRODUCED OHIO OXYGEN ADAPTOR	Jun 18, 1981	Substantially Equivalent	Timeter Instrument Corp.
K811550	TIMETER PRODUCED CHEMETRON (NCG) AIR	Jun 18, 1981	Substantially Equivalent	Timeter Instrument Corp.
K811549	TIMETER PRODUCED SCHRADER OXYGEN ADAPTOR	Jun 18, 1981	Substantially Equivalent	Timeter Instrument Corp.
K810652	TUBING CONNECTORS	Mar 31, 1981	Substantially Equivalent	First Industries, Inc.
K810362	CORRUGATED FLEX TUBING	Mar 17, 1981	Substantially Equivalent	Todd Industries, Inc.
K810344	OXYGEN TUBING	Mar 17, 1981	Substantially Equivalent	Todd Industries, Inc.
K810374	CORRUGATED FLEX TUBING #6000,	Mar 13, 1981	Substantially Equivalent	Todd Industries, Inc.
K802071	OXYGEN SUPPLY TUBING	Sep 16, 1980	Substantially Equivalent	Auburn Components
K801514	TIMETER PRODUCED PURRITAN BENNETT O2 ADP	Jul 14, 1980	Substantially Equivalent	Timeter Instrument Corp.
K801261	DISPOSABLE COUPLING ADAPTOR	Jun 09, 1980	Substantially Equivalent	Intec Medical, Inc.
K801260	DISPOSABLE PRESSURE LINE ADAPTOR	Jun 04, 1980	Substantially Equivalent	Intec Medical, Inc.
K801190	OXYGEN TUBING (CRUSH RESISTANT)/VINYL TP	May 23, 1980	Substantially Equivalent	Airlife, Inc.
K800664	SURE FLOW TUBING	Apr 02, 1980	Substantially Equivalent	B & F Medical Products, Inc.
K800509	CONNECTING TUBES	Mar 25, 1980	Substantially Equivalent	Medi-Craft , Ltd.
K800504	OXYGEN CONNECTING TUBES	Mar 18, 1980	Substantially Equivalent	Medi-Craft , Ltd.
K791851	RED CAP, M-502	Oct 01, 1979	Substantially Equivalent	Mem Medical, Inc.
K791848	RESPIROMETER MANIFOLD M-505	Oct 01, 1979	Substantially Equivalent	Mem Medical, Inc.
K791821	CORRUGATED FLEXIBLE POLYETHYLENE & EVA	Sep 26, 1979	Substantially Equivalent	Airlife, Inc.
K790928	3-WAY T 22MM MALE	May 21, 1979	Substantially Equivalent	Mem Medical, Inc.
K790160	OXYGEN TUBING, W/VINYL AND LATEX TIPS	Feb 08, 1979	Substantially Equivalent	Airlife, Inc.
K790159	CORRUGATED FLEXIBLE E.V.A. TUBING	Feb 08, 1979	Substantially Equivalent	Airlife, Inc.
K790158	TUBING, E.V.A. FLEXIBLE	Feb 08, 1979	Substantially Equivalent	Airlife, Inc.
K790147	TUBING CORRUGATED	Feb 08, 1979	Substantially Equivalent	Airlife, Inc.
K790150	BIRD DRIVE LINE ADAPTOR	Feb 01, 1979	Substantially Equivalent	Airlife, Inc.
K781428	FLEXTUBES:9, 20, 26	Sep 11, 1978	Substantially Equivalent	Bourns Medical Systems, Inc.
K781416	TUBING, FLEXIBLE, MEDICAL GAS	Sep 11, 1978	Substantially Equivalent	Vitalab Products Corp.
K781231	OXYGEN SUPPLY TUBE, DISP., PLASTIC	Sep 11, 1978	Substantially Equivalent	Rtec
K771075	OXYGEN CONNECTING TUBE #017205	Aug 04, 1977	Substantially Equivalent	C.R. Bard, Inc.
K760220	TUBING, SINGLE USE OXYGEN SUPPLY	Aug 03, 1976	Substantially Equivalent	Manner Medical Products