FDA product code BXW: Calibrator, Volume, Gas
BXW is the FDA product code for calibrator, volume, gas. It is a Class I device, regulated under 21 CFR 868.1870 and reviewed by the Anesthesiology panel. FDA has cleared 6 510(k) submissions under BXW, from 6 different applicants. The average 510(k) review took 52 days (median 52).
Classification
| Field | Value |
|---|---|
| Device name | Calibrator, Volume, Gas |
| Device class | Class I |
| Regulation | 21 CFR 868.1870 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BXW clearance
Top BXW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Graphics Corp. | 1 | 1985-12-05 |
| The Perkin-Elmer Corp. | 1 | 1983-07-19 |
| Instrumentation Industries, Inc. | 1 | 1983-05-16 |
| Timeter Instrument Corp. | 1 | 1981-11-16 |
| Ohio Medical Products | 1 | 1981-02-12 |
1 more applicants have BXW clearances. See the full list in Caduvo.
Most recent BXW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K853848 | Medical Graphics Corp. | RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR | 1985-12-05 | 80 |
| K831758 | The Perkin-Elmer Corp. | FLOW-CALIBRATION MODULE | 1983-07-19 | 48 |
| K830898 | Instrumentation Industries, Inc. | SYRINGE 500BC BE #7000 | 1983-05-16 | 56 |
| K812765 | Timeter Instrument Corp. | DATASCRIBE #DS-40 | 1981-11-16 | 42 |
| K810290 | Ohio Medical Products | OHIO CAL-CHEK | 1981-02-12 | 9 |
Recalls for BXW devices
openFDA lists no recalls for product code BXW.
Frequently asked questions
What is FDA product code BXW?
BXW is the FDA product code for calibrator, volume, gas. It is a Class I device, regulated under 21 CFR 868.1870 and reviewed by the Anesthesiology panel.
What device class is BXW?
Class I, regulation 21 CFR 868.1870. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BXW?
Across 6 cleared submissions the average was 52 days from receipt to decision (median 52).
Which companies have the most BXW clearances?
Medical Graphics Corp. (1); The Perkin-Elmer Corp. (1); Instrumentation Industries, Inc. (1); Timeter Instrument Corp. (1); Ohio Medical Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BXW
- Run a recall and safety report across every BXW manufacturer
- Watch product code BXW 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.
All Anesthesiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times