FDA product code BXO: Transducer, Gas Pressure
BXO is the FDA product code for transducer, gas pressure. It is a Class I device, regulated under 21 CFR 868.2900 and reviewed by the Anesthesiology panel. FDA has cleared 2 510(k) submissions under BXO, from 2 different applicants. The average 510(k) review took 48 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Transducer, Gas Pressure |
| Device class | Class I |
| Regulation | 21 CFR 868.2900 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BXO clearance
Top BXO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nihon Kohden America, Inc. | 1 | 1994-08-31 |
| Cns, Inc. | 1 | 1990-03-12 |
Most recent BXO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944027 | Nihon Kohden America, Inc. | AG-839PA CO2 MODULE AND ACCESSORIES | 1994-08-31 | 14 |
| K897107 | Cns, Inc. | POLY G PHYSIOLOGICAL DATA RECORDER | 1990-03-12 | 81 |
Recalls for BXO devices
openFDA lists no recalls for product code BXO.
Frequently asked questions
What is FDA product code BXO?
BXO is the FDA product code for transducer, gas pressure. It is a Class I device, regulated under 21 CFR 868.2900 and reviewed by the Anesthesiology panel.
What device class is BXO?
Class I, regulation 21 CFR 868.2900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BXO?
Across 2 cleared submissions the average was 48 days from receipt to decision (median 48).
Which companies have the most BXO clearances?
Nihon Kohden America, Inc. (1); Cns, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BXO
- Run a recall and safety report across every BXO manufacturer
- Watch product code BXO 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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