JAX
8 FDA 510(k) clearances · Product code
80 daysmedian time to decision
291 days90th percentile
8clearances measured
FDA profile
- Official device name
- Pneumotachometer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2550
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 1995: 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 |
|---|---|---|
| FLOSENSE, MODEL 29-8010 (K990962) | Sdi Diagnostics, Inc. | 2000-01-07 |
| PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS (K921178) | Medical Associated Services, Inc. | 1992-08-26 |
| SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR (K884464) | Spirometrics, Inc. | 1989-01-19 |
| PAX METER (K853085) | Peace Medical, Inc. | 1985-09-03 |
| RESPIRATORY FLOW MODULE (K833265) | Thoratec Laboratories Corp. | 1983-11-28 |
| FLO-COR I (K812825) | Biotrine Corp. | 1981-10-26 |
| RING-ORIFICE, TURBULENT FLOW PNEUMOT (K791730) | Research Development Corp. | 1979-11-16 |
| VO RESPIRATORY PNEUMOTACHOGRAPH (K770061) | Research Development Corp. | 1977-01-14 |
Track JAX automatically
Every clearance here is in the API, with alerts when new ones post.