BXX
10 FDA 510(k) clearances · Product code
49 daysmedian time to decision
134 days90th percentile
10clearances measured
FDA profile
- Official device name
- Calibrator, Pressure, Gas
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.2620
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 1998: 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 |
|---|---|---|
| SINGLE DOSE GAS INJECTOR (K923397) | Escalon Medical Trek | 1992-09-14 |
| RT-200 COMPUTER INTERFACE (K875075) | Timeter Instrument Corp. | 1988-04-21 |
| UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL (K850029) | Utah Medical Products, Inc. | 1985-04-29 |
| RT-200 CALIBRATION ANALYZER (K822746) | Timeter Instrument Corp. | 1982-10-13 |
| NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY (K801256) | Kleen Test Products | 1980-06-04 |
| NEEDLE COUNTER-SURE COUNT/30 CT. MAGN. (K801257) | Kleen Test Products | 1980-06-04 |
| NEEDLE COUNTER-SURE COUNT/10 COUNT (K801258) | Kleen Test Products | 1980-06-04 |
| SPIROCAL (K791294) | Equilibrated Bio Systems, Inc. | 1979-08-16 |
| PORTABLE PNEUMATIC CALIBRATOR 65-150 (K780981) | Pennwalt Corp. | 1978-08-02 |
| PERCI (K780838) | Micro Tronics Corp. | 1978-07-17 |
Track BXX automatically
Every clearance here is in the API, with alerts when new ones post.