Product Code: BXK FDA class 1 21 CFR 868.6400

Gas, Calibration (Specified Concentration)

Anesthesiology

The Gas, Calibration (Specified Concentration) is a gas mixture of precisely known composition used to calibrate medical gas analyzers and monitoring instruments, ensuring measurement accuracy in clinical and laboratory settings. 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 BXK, regulated under 21 CFR 868.6400 in the Anesthesiology specialty.

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Basic Information

Product Code: BXK
Device Class: FDA class 1
Regulation Number: 868.6400
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 32 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K954804	LUNG DIFFUSION MIXTURES	Jan 25, 1996	Substantially Equivalent	Mittler Supply, Inc.
K954803	BLOOD GAS MIXTURES	Jan 25, 1996	Substantially Equivalent	Mittler Supply, Inc.
K954542	LUNG DIFFUSION MIXTURE	Dec 22, 1995	Substantially Equivalent	Liquid Technology Corp.
K952838	MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES	Sep 19, 1995	Substantially Equivalent	Standard Welders Supply Co.
K953934	MED-TECH LUNG DIFFUSION MIXTURE	Sep 18, 1995	Substantially Equivalent	Medical Technical Gases Inc..
K953208	MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES	Jul 20, 1995	Substantially Equivalent	Standard Welders Supply Co.
K944998	CALIBRATION GAS	Feb 03, 1995	Substantially Equivalent	Sunox, Inc.
K944812	CLINICAL BLOOD GAS MIXTURE	Feb 01, 1995	Substantially Equivalent	Laboratory & Specialty Gases, Inc.
K942866	CLINICAL BLOOD GAS MIXTURE	Sep 01, 1994	Substantially Equivalent	Nordan Smith Welding Supplies
K932874	BLOOD GAS MIXTURE	Jan 27, 1994	Substantially Equivalent	Tri-Gas, Inc.
K935311	CLINICAL BLOOD GAS	Dec 22, 1993	Substantially Equivalent	Acetylene Gas Co.
K932520	CALIBRATION GAS	Aug 19, 1993	Substantially Equivalent	Cryodyne Technologies, Inc.
K924796	LUNG DIFFUSION GAS MIXTURE	Dec 17, 1992	Substantially Equivalent	Gulf States Airgas
K924795	BLOOD GAS MIXTURE	Dec 17, 1992	Substantially Equivalent	Gulf States Airgas
K911264	CALIBRATION KIT	Aug 02, 1991	Substantially Equivalent	S & W Medico Teknik
K911471	LUNG DIFFUSION GAS MIXTURES	Jun 18, 1991	Substantially Equivalent	Norco, Inc.
K902754	ANESTHETIC GAS CALIBRATION MIXTURE	Dec 19, 1990	Substantially Equivalent	Liquid Air Corp.
K882210	MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES	Jun 21, 1988	Substantially Equivalent	Linde Div. Union Carbide Corp.
K873586	LUNG DIFFUSION GAS	Feb 12, 1988	Substantially Equivalent	National Welders
K874297	CALIBRATION GAS FOR CARBON DIOXIDE MONITOR	Dec 21, 1987	Substantially Equivalent	Liquid Air Corp.
K873587	BLOOD ANALYSIS GAS	Oct 30, 1987	Substantially Equivalent	National Welders
K871100	O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP	Apr 21, 1987	Substantially Equivalent	Matheson Gas Products, Inc.
K871103	O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P	Apr 20, 1987	Substantially Equivalent	Matheson Gas Products, Inc.
K871102	O.1 TO 50.0% CARBON DIOXIDE, USP BALANCE NITRO.,NF	Apr 20, 1987	Substantially Equivalent	Matheson Gas Products, Inc.
K871101	0.1 TO 25.0% OXYGEN, USP, BALANCE NITROGEN, N.F.	Apr 20, 1987	Substantially Equivalent	Matheson Gas Products, Inc.
K870139	GAS, CALIBRATION, SPECIFIED CONCENTRATION	Feb 10, 1987	Substantially Equivalent	Portland Welding Supply, Inc.
K863675	CALIBRATION GAS FOR SERVO GAS MONITOR 120	Nov 03, 1986	Substantially Equivalent	Siemens Elema AB
K822764	LUNG DIFFUSION MIXTURE	Oct 22, 1982	Substantially Equivalent	Liquid Carbonic Corp.
K822763	CLINICAL GAS MIXTURE-NON-FLAMMABLE	Oct 22, 1982	Substantially Equivalent	Liquid Carbonic Corp.
K822762	CLINICAL GAS MIXTURE-FLAMMABLE	Oct 22, 1982	Substantially Equivalent	Liquid Carbonic Corp.
K822753	BLOOD GAS MIXTURE	Oct 22, 1982	Substantially Equivalent	Liquid Carbonic Corp.
K822752	ANAEROBIC CARBON DIOXIDE	Oct 22, 1982	Substantially Equivalent	Liquid Carbonic Corp.