FKK
6 FDA 510(k) clearances · Product code
55 daysmedian time to decision
79 days90th percentile
6clearances measured
FDA profile
- Official device name
- Clamp, Line
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4730
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1994: 1 · 2008: 4
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 |
|---|---|---|
| TUBING CLAMP CAT#1000-A (K854512) | Rao Medical Devices, Inc. | 1985-12-02 |
| NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET (K854517) | Travenol Laboratories, S.A. | 1985-12-02 |
| CLAMP, TUBING, LINE (K844121) | Dyn-A-Med Products | 1984-12-17 |
| EMPTY DIALYSATE CONTAINER (K831689) | Delmed, Inc. | 1983-08-11 |
| AMP CAPD UNISPIKE AMINISTRATION SET (K822551) | American Medical Products, Inc. | 1982-10-13 |
| FLOWCLAMP CAT.#1011 & 1012 (K802009) | Pollak (Intl.), Ltd. | 1980-10-31 |
Track FKK automatically
Every clearance here is in the API, with alerts when new ones post.