FKG
6 FDA 510(k) clearances · Product code
104 daysmedian time to decision
916 days90th percentile
6clearances measured
FDA profile
- Official device name
- Tray, Start/Stop (Including Contents), Dialysis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- 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 |
|---|---|---|
| JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT (K925469) | J.J. Skinner, Inc. | 1995-05-03 |
| KITS AND TRAYS FOR DIALYSIS USE (K871630) | Dove Medical Supplies | 1987-05-26 |
| CAPD PREP KIT (K833780) | Professional Dialysis Products | 1984-02-09 |
| DIALYIS START CARE KIT (K802361) | Med-Pak Corp. | 1981-01-16 |
| PERIDIAL PERITONEAL DIALYSIS TRAY (K792207) | Cutter Laboratories, Inc. | 1979-12-10 |
| ACUTE RENAL DIALYSIS TRAY (K790353) | Argon Medical Corp. | 1979-04-20 |
Track FKG automatically
Every clearance here is in the API, with alerts when new ones post.