Product Code: BZO FDA class 1 21 CFR 868.5975

Set, Tubing And Support, Ventilator (W Harness)

Anesthesiology

The Set, Tubing and Support, Ventilator (W Harness) consists of the tubing, connectors, and harness assembly used to deliver gases from a ventilator to a patient's airway, forming the patient circuit of the ventilator system. 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 BZO, regulated under 21 CFR 868.5975 in the Anesthesiology specialty.

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510(k)s

FEI Numbers

151

Registration Numbers

151

Unique Applicants

Years Active

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Basic Information

Product Code: BZO
Device Class: FDA class 1
Regulation Number: 868.5975
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 88 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K953784	UNICOR, INC. CORRUGATED TUBING	Sep 19, 1995	Substantially Equivalent	Unicor, Inc.
K953785	UNICOR, INC. VENTILATOR HOSES	Sep 18, 1995	Substantially Equivalent	Unicor, Inc.
K952022	PRIMA VOLUMN VENTILATORSS	May 22, 1995	Substantially Equivalent	Prima, Inc.
K952012	PRIMA CUSTOM ANESTESIA CIRCUIT	May 22, 1995	Substantially Equivalent	Prima, Inc.
K952011	PRIMA BREATHING BAGS	May 22, 1995	Substantially Equivalent	Prima, Inc.
K952010	PRIMA VENTILATOR HOSES	May 22, 1995	Substantially Equivalent	Prima, Inc.
K945740	INFANT FLOW SYSTEM	Mar 23, 1995	Substantially Equivalent	Hamilton Medical, Inc.
K944531	PRIMA, INC. CORRUGATED TUBING	Dec 02, 1994	Substantially Equivalent	Prima, Inc.
K942572	VOLUME VENTILATOR	Jun 10, 1994	Substantially Equivalent	Med-Plastics Intl., Inc.
K942569	VENTILATOR HOSE	Jun 10, 1994	Substantially Equivalent	Med-Plastics Intl., Inc.
K935582	TUBE, INHALER OXYGEN	Jan 14, 1994	Substantially Equivalent	Puritas Health Care, Inc.
K934753	STAR BREATHING CIRCUITS	Oct 27, 1993	Substantially Equivalent	Infrasonics Corp.
K932706	PRECISION MED PRODUCTS LTD. VENTILATOR HOSE	Jul 23, 1993	Substantially Equivalent	Precision Med Products, Ltd.
K932712	PRECISION MED PRODUCTS LTD VOLUME VENTILATORS	Jul 22, 1993	Substantially Equivalent	Precision Med Products, Ltd.
K932560	VOLUME VENTILATORS	Jul 22, 1993	Substantially Equivalent	Life Shield Healthcare Products, Inc.
K932563	VENTILATOR HOSES	Jul 16, 1993	Substantially Equivalent	Life Shield Healthcare Products, Inc.
K932119	CLEVELAND TUBING, INC. VENTILATOR HOSES	Jun 23, 1993	Substantially Equivalent	Cleveland Tubing, Inc.
K922479	DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED	Oct 30, 1992	Substantially Equivalent	Intertech Resources, Inc.
K921510	GAS SAMPLING KIT MODIFICATION	Jun 11, 1992	Substantially Equivalent	Respiratory Support Products, Inc.
K911328	UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION	Aug 15, 1991	Substantially Equivalent	Intertech Resources, Inc.
K903083	NEONATAL VENTILATOR CIRCUIT	Dec 27, 1990	Substantially Equivalent	Hudson Respiratory Care, Inc.
K903055	EXTENDED LIFE CIRCUITS	Nov 09, 1990	Substantially Equivalent	Pharma Systems, Inc.
K903404	FLOCARE F	Sep 25, 1990	Substantially Equivalent	Flocare Medical
K896439	TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE	Jan 09, 1990	Substantially Equivalent	Ventlab Corp.
K895853	SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT	Dec 22, 1989	Substantially Equivalent	Sechrist Industries, Inc.
K893760	CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004	Aug 10, 1989	Substantially Equivalent	Nova-Ventrx
K890822	CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE)	May 05, 1989	Substantially Equivalent	Ventlab Corp.
K890011	OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING	Mar 20, 1989	Substantially Equivalent	Life Design Systems, Inc.
K884525	PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT	Dec 16, 1988	Substantially Equivalent	Intertech/Ohio
K882341	QUICK CONNECT T ADAPTOR	Jul 18, 1988	Substantially Equivalent	Thayer Medical Corp.
K880959	LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY	Apr 14, 1988	Substantially Equivalent	Lifeguard Medical Products, Inc.
K880637	BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES	Apr 11, 1988	Substantially Equivalent	Baxter Healthcare Corp
K874559	BABYFLEX PATIENT CIRCUIT	Dec 21, 1987	Substantially Equivalent	Airoflex Medical, Inc.
K873900	PORTABLE VENTILATOR PATIENT CIRCUIT	Oct 30, 1987	Substantially Equivalent	Puritan Bennett Corp.
K873927	REUSEABLE BREATHING TUBES	Oct 20, 1987	Substantially Equivalent	Dryden Corp.
K863756	MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT	Nov 13, 1986	Substantially Equivalent	Nova-Ventrx
K863910	RAINCOAT	Oct 20, 1986	Substantially Equivalent	Artec Environmental Monitoring Division
K863033	PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS	Aug 20, 1986	Substantially Equivalent	Intertech/Ohio
K860659	END TIDAL CO2 SAMPLING CIRCUIT	Apr 17, 1986	Substantially Equivalent	Life Design Systems, Inc.
K861286	GAS SAMPLING KIT	Apr 11, 1986	Substantially Equivalent	Respiratory Support Products, Inc.
K860880	VENTILATOR CIRCUITS (VARIOUS TYPES)	Mar 20, 1986	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K860879	DISPOSABLE VENTILATOR CIRCUITS	Mar 20, 1986	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K850151	L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT	Jul 19, 1985	Substantially Equivalent	Life Products, Inc.
K850600	CO-AX VENTILATOR CIRCUIT	May 02, 1985	Substantially Equivalent	Nova-Ventrx
K850703	SAF T FLO VENTILATOR TUBING	Mar 25, 1985	Substantially Equivalent	Bivona Medical Technologies
K844290	L100D PATIENT CIRCUIT DUAL LINE	Jan 10, 1985	Substantially Equivalent	Life Products, Inc.
K843036	PATIENT BREATHING CIRCUIT	Aug 15, 1984	Substantially Equivalent	Infrasonics Corp.
K842778	AVATRON UNIVERSAL ADULT VOL. VENTILATOR	Jul 26, 1984	Substantially Equivalent	Avatron, Inc.
K842389	AVATRON DISPOSABLE I.P.P.B. CIRUCIT	Jun 26, 1984	Substantially Equivalent	Avatron, Inc.
K841657	PATIENT TUBING HYTREL SIEMENS-ELEMA	May 23, 1984	Substantially Equivalent	Siemens Elema AB
K841722	MASS SPECTROMETER INTERFACE	May 14, 1984	Substantially Equivalent	Dryden Corp.
K841637	THREE PORT SENSOR MANIFOLD	May 02, 1984	Substantially Equivalent	Dryden Corp.
K841378	VENT-WELL VENTILATOR TUBING	May 02, 1984	Substantially Equivalent	Airmed Corp.
K834569	VENTILATORY FREQUENCY MONITOR	Mar 30, 1984	Substantially Equivalent	Cryo Corp.
K834570	VOLUME VENTILATOR CIRCUIT W/WATER TRAP	Mar 05, 1984	Substantially Equivalent	Airlife, Inc.
K833459	COAXIAL VOL. VENTILATOR CIRCUIT	Jan 10, 1984	Substantially Equivalent	Airco/Ohio Medical Products
K832681	UNIVERSAL VOL. VENTILATOR 72 #1626	Sep 26, 1983	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K830923	TEMP-CHECK ADAPTOR, STRAIGHT CONFIGURA	May 03, 1983	Substantially Equivalent	Cygnus Research Corp.
K830922	TEMP-CHECK ADAPTOR, TEE-CONFIGURATION	May 02, 1983	Substantially Equivalent	Cygnus Research Corp.
K830921	TEMP-CHECK ADAPTOR, Y-CONFIGURATION	May 02, 1983	Substantially Equivalent	Cygnus Research Corp.
K823481	BE #16 - MANIFOLD	Dec 22, 1982	Substantially Equivalent	Instrumentation Industries, Inc.
K823271	DISPOSABLE ADULT VO. VENTILATOR CIRCUIT	Dec 22, 1982	Substantially Equivalent	Intec Medical, Inc.
K823479	MODUFLEX NEONATAL VENTILATOR SET	Dec 15, 1982	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K823287	RESPIRATORY CIRCUIT ADAPTOR	Dec 09, 1982	Substantially Equivalent	Thoratec Laboratories Corp.
K821064	INSPIRON NEONATAL VENTILATOR CIRCUIT	May 03, 1982	Substantially Equivalent	C.R. Bard, Inc.
K820128	UNI-SET	Mar 23, 1982	Substantially Equivalent	Inhalation Therapy Equipment, Co.
K820131	3M VOLUME VENTIATOR CIRCUIT	Jan 28, 1982	Substantially Equivalent	3M Company
K813384	DISPOSABLE NEONATAL VENTILATION CIRCUIT	Jan 07, 1982	Substantially Equivalent	Intec.
K813155	PEDIATRIC VENTILATOR CIRCUIT 2C7131	Dec 09, 1981	Substantially Equivalent	Travenol Laboratories, S.A.
K812774	VENTILATOR CIRCUIT	Oct 23, 1981	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K812773	BENNETT VOLUME VENTILATOR CIRCUIT	Oct 23, 1981	Substantially Equivalent	Ideal Medical, Inc.
K812737	RAIN-X	Oct 23, 1981	Substantially Equivalent	Nova-Ventrx
K810341	LIFELINE IPPB SET-UP	Mar 17, 1981	Substantially Equivalent	Todd Industries, Inc.
K801859	CAM-10 RESPIRATORY HOSE ASSEMBLIES	Sep 09, 1980	Substantially Equivalent	Lifecare Services, Inc.
K801087	NEONATAL BREATHING CIRCUIT SYSTEM	May 23, 1980	Substantially Equivalent	Isothermal Systems, Inc.
K792268	CIRCAPAK	Nov 27, 1979	Substantially Equivalent	Respiratory Care, Inc.
K792047	CIRCUIT, BREATHING (W/ CONNECTOR, ADAPT,	Oct 30, 1979	Substantially Equivalent	Airlife, Inc.
K792030	TWO-PIECE I.P.P.B. MANIFOLD-WITH RIGHT	Oct 30, 1979	Substantially Equivalent	Airlife, Inc.
K791761	CIRCUIT, BREATHING W/WO NEBULIZER	Oct 26, 1979	Substantially Equivalent	Airlife, Inc.
K791856	Y & ELBOW W/WO PORTS	Sep 26, 1979	Substantially Equivalent	Airlife, Inc.
K791469	MANIFOLD/NEBULIZER BREATHING PRODUCTS	Aug 28, 1979	Substantially Equivalent	Hospitak, Inc.
K791060	RAIN-X	Jun 15, 1979	Substantially Equivalent	Sherwood Medical Co.
K791034	PIGGYBACK BREATHING CIRCUIT	Jun 15, 1979	Substantially Equivalent	Vital Signs, Inc.
K772069	VOL. VENTILATOR SETUP W/OUT NEBULIZER	Nov 15, 1977	Substantially Equivalent	Inspiron Corp.
K770593	CORRUGATED TUBING #770 & 771	Apr 19, 1977	Substantially Equivalent	Surgicot, Inc.
K770581	CORRUGATED TUBING, 770 & 771	Apr 19, 1977	Substantially Equivalent	C.D. & F. Corp.
K770354	TUBING, AEROSAL, DISPOSABLE	Mar 16, 1977	Substantially Equivalent	Inhal-O-Tech Medical Plastic
K760993	MECK/MILLER VENTILATION TUBE HARNESS	Dec 09, 1976	Substantially Equivalent	Timeter Instrument Corp.