Product code BXK— Anesthesiology
BLOOD GAS MIXTURE
- Classification name
- Gas, Calibration (Specified Concentration)
- Device class
- Class 1
- Regulation
- 21 CFR 868.6400
- Advisory panel
- Anesthesiology
- Total cleared
- 32
- First cleared
- Most recent
Market context for product code BXK
FDA has cleared devices under product code BXK between 1982 and 1996, filed by 20 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1988
- 1987
- 1986
- 1982
Top applicants under product code BXK
Recent clearances under product code BXK
- K954803 — BLOOD GAS MIXTURES
- K954804 — LUNG DIFFUSION MIXTURES
- K954542 — LUNG DIFFUSION MIXTURE
- K952838 — MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES
- K953934 — MED-TECH LUNG DIFFUSION MIXTURE
- K953208 — MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURES
- K944998 — CALIBRATION GAS
- K944812 — CLINICAL BLOOD GAS MIXTURE
- K942866 — CLINICAL BLOOD GAS MIXTURE
- K932874 — BLOOD GAS MIXTURE
- K935311 — CLINICAL BLOOD GAS
- K932520 — CALIBRATION GAS
- K924795 — BLOOD GAS MIXTURE
- K924796 — LUNG DIFFUSION GAS MIXTURE
- K911264 — CALIBRATION KIT
- K911471 — LUNG DIFFUSION GAS MIXTURES
- K902754 — ANESTHETIC GAS CALIBRATION MIXTURE
- K882210 — MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES
- K873586 — LUNG DIFFUSION GAS
- K874297 — CALIBRATION GAS FOR CARBON DIOXIDE MONITOR
- K873587 — BLOOD ANALYSIS GAS
- K871100 — O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP
- K871101 — 0.1 TO 25.0% OXYGEN, USP, BALANCE NITROGEN, N.F.
- K871102 — O.1 TO 50.0% CARBON DIOXIDE, USP BALANCE NITRO.,NF
- K871103 — O.1 T0 40.0% CARBON DIOX. O.1 TO 90.0% OXY. U.S.P
- K870139 — GAS, CALIBRATION, SPECIFIED CONCENTRATION
- K863675 — CALIBRATION GAS FOR SERVO GAS MONITOR 120
- K822752 — ANAEROBIC CARBON DIOXIDE
- K822753 — BLOOD GAS MIXTURE
- K822762 — CLINICAL GAS MIXTURE-FLAMMABLE
- K822763 — CLINICAL GAS MIXTURE-NON-FLAMMABLE
- K822764 — LUNG DIFFUSION MIXTURE
Data sourced from openFDA. This site is unofficial and independent of the FDA.