Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

BXK — Predicate Candidate Screening

32 FDA 510(k) clearances under this product code; the 50 most recent screened below.

62 daysmedian FDA review time

144 days90th percentile

32clearances measured

K-number	Device	Applicant	Decided	Review days
K954803	BLOOD GAS MIXTURES	Mittler Supply, Inc.	1996-01-25	98
K954804	LUNG DIFFUSION MIXTURES	Mittler Supply, Inc.	1996-01-25	98
K954542	LUNG DIFFUSION MIXTURE	Liquid Technology Corp.	1995-12-22	84
K952838	MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES	Standard Welders Supply Co.	1995-09-19	92
K953934	MED-TECH LUNG DIFFUSION MIXTURE	Medical Technical Gases Inc..	1995-09-18	31
K953208	MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES	Standard Welders Supply Co.	1995-07-20	31
K944998	CALIBRATION GAS	Sunox, Inc.	1995-02-03	113
K944812	CLINICAL BLOOD GAS MIXTURE	Laboratory & Specialty Gases, Inc.	1995-02-01	125
K942866	CLINICAL BLOOD GAS MIXTURE	Nordan Smith Welding Supplies	1994-09-01	76
K932874	BLOOD GAS MIXTURE	Tri-Gas, Inc.	1994-01-27	227
K935311	CLINICAL BLOOD GAS	Acetylene Gas Co.	1993-12-22	50
K932520	CALIBRATION GAS	Cryodyne Technologies, Inc.	1993-08-19	86
K924795	BLOOD GAS MIXTURE	Gulf States Airgas	1992-12-17	85
K924796	LUNG DIFFUSION GAS MIXTURE	Gulf States Airgas	1992-12-17	85
K911264	CALIBRATION KIT	S & W Medico Teknik	1991-08-02	144
K911471	LUNG DIFFUSION GAS MIXTURES	Norco, Inc.	1991-06-18	76
K902754	ANESTHETIC GAS CALIBRATION MIXTURE	Liquid Air Corp.	1990-12-19	180
K882210	MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES	Linde Div. Union Carbide Corp.	1988-06-21	26
K873586	LUNG DIFFUSION GAS	National Welders	1988-02-12	161
K874297	CALIBRATION GAS FOR CARBON DIOXIDE MONITOR	Liquid Air Corp.	1987-12-21	62
K873587	BLOOD ANALYSIS GAS	National Welders	1987-10-30	56
K871100	O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP	Matheson Gas Products, Inc.	1987-04-21	33
K871102	O.1 TO 50.0% CARBON DIOXIDE, USP BALANCE NITRO.,NF	Matheson Gas Products, Inc.	1987-04-20	32
K871101	0.1 TO 25.0% OXYGEN, USP, BALANCE NITROGEN, N.F.	Matheson Gas Products, Inc.	1987-04-20	32
K871103	O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P	Matheson Gas Products, Inc.	1987-04-20	32
K870139	GAS, CALIBRATION, SPECIFIED CONCENTRATION	Portland Welding Supply, Inc.	1987-02-10	28
K863675	CALIBRATION GAS FOR SERVO GAS MONITOR 120	Siemens Elema AB	1986-11-03	45
K822763	CLINICAL GAS MIXTURE-NON-FLAMMABLE	Liquid Carbonic Corp.	1982-10-22	38
K822764	LUNG DIFFUSION MIXTURE	Liquid Carbonic Corp.	1982-10-22	38
K822762	CLINICAL GAS MIXTURE-FLAMMABLE	Liquid Carbonic Corp.	1982-10-22	38
K822752	ANAEROBIC CARBON DIOXIDE	Liquid Carbonic Corp.	1982-10-22	39
K822753	BLOOD GAS MIXTURE	Liquid Carbonic Corp.	1982-10-22	39

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda