FDA product code BXA: Analyzer, Gas, Water Vapor, Gaseous-Phase
BXA is the FDA product code for analyzer, gas, water vapor, gaseous-phase. It is a Class I device, regulated under 21 CFR 868.1975 and reviewed by the Anesthesiology panel. FDA has cleared 2 510(k) submissions under BXA, from 2 different applicants. The average 510(k) review took 14 days (median 14).
Classification
| Field | Value |
|---|---|
| Device name | Analyzer, Gas, Water Vapor, Gaseous-Phase |
| Device class | Class I |
| Regulation | 21 CFR 868.1975 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BXA clearance
Top BXA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Isothermal Systems, Inc. | 1 | 1977-08-16 |
| Sherwood Medical Industries | 1 | 1976-08-04 |
Most recent BXA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K771510 | Isothermal Systems, Inc. | SERVO-PAK MOLEL 0030 | 1977-08-16 | 11 |
| K760246 | Sherwood Medical Industries | ENDOTRACHEAL T CONNECTOR | 1976-08-04 | 16 |
Recalls for BXA devices
openFDA lists no recalls for product code BXA.
Frequently asked questions
What is FDA product code BXA?
BXA is the FDA product code for analyzer, gas, water vapor, gaseous-phase. It is a Class I device, regulated under 21 CFR 868.1975 and reviewed by the Anesthesiology panel.
What device class is BXA?
Class I, regulation 21 CFR 868.1975. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BXA?
Across 2 cleared submissions the average was 14 days from receipt to decision (median 14).
Which companies have the most BXA clearances?
Isothermal Systems, Inc. (1); Sherwood Medical Industries (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BXA
- Run a recall and safety report across every BXA manufacturer
- Watch product code BXA 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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