BXR
6 FDA 510(k) clearances · Product code
165 daysmedian time to decision
194 days90th percentile
6clearances measured
FDA profile
- Official device name
- Meter, Airway Pressure (Inspiratory Force)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1780
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2002: 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 |
|---|---|---|
| NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS (K081693) | Instrumentation Industries, Inc. | 2008-09-11 |
| MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER (K032593) | Mercury Medical | 2004-02-03 |
| COLLINS DIGITAL PULMONARY MANOMETER (K912946) | Warren E. Collins, Inc. | 1992-01-15 |
| THAYER MIP ADAPTER (K904917) | Thayer Medical Corp. | 1991-01-28 |
| DIGITAL MANOMETER (DM 50) (K901998) | Medical Support Products, Inc. | 1990-07-25 |
| INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING (K873498) | Dhd Medical Products Div. Diemolding Corp. | 1988-03-09 |
Track BXR automatically
Every clearance here is in the API, with alerts when new ones post.