Atlas FDA

BXK

32 FDA 510(k) clearances · Product code

62 daysmedian time to decision
144 days90th percentile
32clearances measured

FDA profile

Official device name
Gas, Calibration (Specified Concentration)
Device class
Class I (low risk)
Regulation
21 CFR 868.6400
Medical specialty
Anesthesiology
Adverse events (MAUDE)
1998: 1 · 2001: 1 · 2004: 1 · 2005: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BLOOD GAS MIXTURES (K954803)Mittler Supply, Inc.1996-01-25
LUNG DIFFUSION MIXTURES (K954804)Mittler Supply, Inc.1996-01-25
LUNG DIFFUSION MIXTURE (K954542)Liquid Technology Corp.1995-12-22
MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES (K952838)Standard Welders Supply Co.1995-09-19
MED-TECH LUNG DIFFUSION MIXTURE (K953934)Medical Technical Gases Inc..1995-09-18
MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES (K953208)Standard Welders Supply Co.1995-07-20
CALIBRATION GAS (K944998)Sunox, Inc.1995-02-03
CLINICAL BLOOD GAS MIXTURE (K944812)Laboratory & Specialty Gases, Inc.1995-02-01
CLINICAL BLOOD GAS MIXTURE (K942866)Nordan Smith Welding Supplies1994-09-01
BLOOD GAS MIXTURE (K932874)Tri-Gas, Inc.1994-01-27
CLINICAL BLOOD GAS (K935311)Acetylene Gas Co.1993-12-22
CALIBRATION GAS (K932520)Cryodyne Technologies, Inc.1993-08-19
BLOOD GAS MIXTURE (K924795)Gulf States Airgas1992-12-17
LUNG DIFFUSION GAS MIXTURE (K924796)Gulf States Airgas1992-12-17
CALIBRATION KIT (K911264)S & W Medico Teknik1991-08-02
LUNG DIFFUSION GAS MIXTURES (K911471)Norco, Inc.1991-06-18
ANESTHETIC GAS CALIBRATION MIXTURE (K902754)Liquid Air Corp.1990-12-19
MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES (K882210)Linde Div. Union Carbide Corp.1988-06-21
LUNG DIFFUSION GAS (K873586)National Welders1988-02-12
CALIBRATION GAS FOR CARBON DIOXIDE MONITOR (K874297)Liquid Air Corp.1987-12-21
BLOOD ANALYSIS GAS (K873587)National Welders1987-10-30
O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP (K871100)Matheson Gas Products, Inc.1987-04-21
O.1 TO 50.0% CARBON DIOXIDE, USP BALANCE NITRO.,NF (K871102)Matheson Gas Products, Inc.1987-04-20
0.1 TO 25.0% OXYGEN, USP, BALANCE NITROGEN, N.F. (K871101)Matheson Gas Products, Inc.1987-04-20
O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P (K871103)Matheson Gas Products, Inc.1987-04-20
GAS, CALIBRATION, SPECIFIED CONCENTRATION (K870139)Portland Welding Supply, Inc.1987-02-10
CALIBRATION GAS FOR SERVO GAS MONITOR 120 (K863675)Siemens Elema AB1986-11-03
CLINICAL GAS MIXTURE-NON-FLAMMABLE (K822763)Liquid Carbonic Corp.1982-10-22
LUNG DIFFUSION MIXTURE (K822764)Liquid Carbonic Corp.1982-10-22
CLINICAL GAS MIXTURE-FLAMMABLE (K822762)Liquid Carbonic Corp.1982-10-22
ANAEROBIC CARBON DIOXIDE (K822752)Liquid Carbonic Corp.1982-10-22
BLOOD GAS MIXTURE (K822753)Liquid Carbonic Corp.1982-10-22

Track BXK automatically

Every clearance here is in the API, with alerts when new ones post.