BXW
6 FDA 510(k) clearances · Product code
56 daysmedian time to decision
80 days90th percentile
6clearances measured
FDA profile
- Official device name
- Calibrator, Volume, Gas
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.1870
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 1993: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR (K853848) | Medical Graphics Corp. | 1985-12-05 |
| FLOW-CALIBRATION MODULE (K831758) | The Perkin-Elmer Corp. | 1983-07-19 |
| SYRINGE 500BC BE #7000 (K830898) | Instrumentation Industries, Inc. | 1983-05-16 |
| DATASCRIBE #DS-40 (K812765) | Timeter Instrument Corp. | 1981-11-16 |
| OHIO CAL-CHEK (K810290) | Ohio Medical Products | 1981-02-12 |
| CALIPERS, MCGAW SKINFOLD (K760520) | Mcgaw Laboratories | 1976-11-12 |
Track BXW automatically
Every clearance here is in the API, with alerts when new ones post.