KRK
9 FDA 510(k) clearances · Product code
47 daysmedian time to decision
218 days90th percentile
9clearances measured
FDA profile
- Official device name
- Manometer, Blood-Pressure, Venous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1140
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1993: 2 · 1995: 1 · 1996: 1 · 2000: 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 |
|---|---|---|
| UST-5268P-5 TRANSDUCER (K950607) | Aloka Co., Ltd. | 1995-09-15 |
| CENTRAL VENOUS PRESSURE MANOMETER (K904674) | Medex, Inc. | 1990-12-27 |
| ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK (K884386) | Ethitek Pharmaceuticals Co. | 1989-01-05 |
| MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER (K875322) | Schneider-Shilley (Usa) | 1988-03-28 |
| SCHNEIDER-SHILEY PRESSURE MANOMETER (K861605) | Shiley, Inc. | 1986-05-28 |
| MANOMETER SET C.V.P. #S 298/299 (K830910) | Exco, Inc. | 1983-04-05 |
| MEDIFIX (K813498) | Burron Medical Products, Inc. | 1982-01-07 |
| MEDIFIX GRADUATED SCALE (K813195) | Burron Medical Products, Inc. | 1981-12-29 |
| VENOUS PRESSURE MONITOR, MF 35 LF (K790668) | Deco Medical, Inc. | 1979-05-23 |
Track KRK automatically
Every clearance here is in the API, with alerts when new ones post.