FDA product code BXX: Calibrator, Pressure, Gas
BXX is the FDA product code for calibrator, pressure, gas. It is a Class I device, regulated under 21 CFR 868.2620 and reviewed by the Anesthesiology panel. FDA has cleared 10 510(k) submissions under BXX, from 7 different applicants. The average 510(k) review took 51 days (median 43).
Classification
| Field | Value |
|---|---|
| Device name | Calibrator, Pressure, Gas |
| Device class | Class I |
| Regulation | 21 CFR 868.2620 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BXX clearance
Top BXX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kleen Test Products | 3 | 1980-06-04 |
| Timeter Instrument Corp. | 2 | 1988-04-21 |
| Escalon Medical Trek | 1 | 1992-09-14 |
| Utah Medical Products, Inc. | 1 | 1985-04-29 |
| Equilibrated Bio Systems, Inc. | 1 | 1979-08-16 |
2 more applicants have BXX clearances. See the full list in Caduvo.
Most recent BXX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K923397 | Escalon Medical Trek | SINGLE DOSE GAS INJECTOR | 1992-09-14 | 66 |
| K875075 | Timeter Instrument Corp. | RT-200 COMPUTER INTERFACE | 1988-04-21 | 134 |
| K850029 | Utah Medical Products, Inc. | UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL | 1985-04-29 | 115 |
| K822746 | Timeter Instrument Corp. | RT-200 CALIBRATION ANALYZER | 1982-10-13 | 33 |
| K801257 | Kleen Test Products | NEEDLE COUNTER-SURE COUNT/30 CT. MAGN. | 1980-06-04 | 7 |
Recalls for BXX devices
openFDA lists no recalls for product code BXX.
Frequently asked questions
What is FDA product code BXX?
BXX is the FDA product code for calibrator, pressure, gas. It is a Class I device, regulated under 21 CFR 868.2620 and reviewed by the Anesthesiology panel.
What device class is BXX?
Class I, regulation 21 CFR 868.2620. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BXX?
Across 10 cleared submissions the average was 51 days from receipt to decision (median 43).
Which companies have the most BXX clearances?
Kleen Test Products (3); Timeter Instrument Corp. (2); Escalon Medical Trek (1); Utah Medical Products, Inc. (1); Equilibrated Bio Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BXX
- Run a recall and safety report across every BXX manufacturer
- Watch product code BXX 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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