BXKClass I

Gas, Calibration (Specified Concentration)

21 CFR 868.6400 / Anesthesiology

BXK is the FDA product code for Gas, Calibration (Specified Concentration), a class I device type, regulated under 21 CFR 868.6400. As of 2026-09-10, FDA records hold 32 510(k) clearances under this code, the most recent dated 1996-01-25, and no recalls.

Classification record

Product code: BXK
Device name: Gas, Calibration (Specified Concentration)
Regulation: 21 CFR 868.6400
Device class: Class I
Review panel: Anesthesiology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 32
Ingested recalls: 0

Clearances, product code BXK

By decision year

32 clearances under product code BXK with a decision year between 1982 and 1996, 1987 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code BXK by decision year
Year	Clearances
1982	5
1986	1
1987	7
1988	2
1990	1
1991	2
1992	2
1993	2
1994	2
1995	6
1996	2

Applicants with the most clearances

Product code BXK

Applicants holding the most 510(k) clearances under product code BXK
Applicant	Clearances
Liquid Carbonic Corp.	5
Matheson Gas Products, Inc.	4
Gulf States Airgas	2
Liquid Air Corp.	2
Mittler Supply, Inc.	2
National Welders	2
Standard Welders Supply Co.	2
Acetylene Gas Co.	1
Cryodyne Technologies, Inc.	1
Laboratory & Specialty Gases, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order