FDA product code BXK: Gas, Calibration (Specified Concentration)
BXK is the FDA product code for gas, calibration (specified concentration). It is a Class I device, regulated under 21 CFR 868.6400 and reviewed by the Anesthesiology panel. FDA has cleared 32 510(k) submissions under BXK, from 20 different applicants. The average 510(k) review took 74 days (median 59).
Classification
| Field | Value |
|---|---|
| Device name | Gas, Calibration (Specified Concentration) |
| Device class | Class I |
| Regulation | 21 CFR 868.6400 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BXK clearance
Top BXK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Liquid Carbonic Corp. | 5 | 1982-10-22 |
| Matheson Gas Products, Inc. | 4 | 1987-04-21 |
| Mittler Supply, Inc. | 2 | 1996-01-25 |
| Standard Welders Supply Co. | 2 | 1995-09-19 |
| Gulf States Airgas | 2 | 1992-12-17 |
15 more applicants have BXK clearances. See the full list in Caduvo.
Most recent BXK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K954803 | Mittler Supply, Inc. | BLOOD GAS MIXTURES | 1996-01-25 | 98 |
| K954804 | Mittler Supply, Inc. | LUNG DIFFUSION MIXTURES | 1996-01-25 | 98 |
| K954542 | Liquid Technology Corp. | LUNG DIFFUSION MIXTURE | 1995-12-22 | 84 |
| K952838 | Standard Welders Supply Co. | MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES | 1995-09-19 | 92 |
| K953934 | Medical Technical Gases Inc.. | MED-TECH LUNG DIFFUSION MIXTURE | 1995-09-18 | 31 |
Recalls for BXK devices
openFDA lists no recalls for product code BXK.
Frequently asked questions
What is FDA product code BXK?
BXK is the FDA product code for gas, calibration (specified concentration). It is a Class I device, regulated under 21 CFR 868.6400 and reviewed by the Anesthesiology panel.
What device class is BXK?
Class I, regulation 21 CFR 868.6400. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BXK?
Across 32 cleared submissions the average was 74 days from receipt to decision (median 59).
Which companies have the most BXK clearances?
Liquid Carbonic Corp. (5); Matheson Gas Products, Inc. (4); Mittler Supply, Inc. (2); Standard Welders Supply Co. (2); Gulf States Airgas (2).
Next steps
- Run an FDA pathway report with predicate devices for product code BXK
- Run a recall and safety report across every BXK manufacturer
- Watch product code BXK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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