FKL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Insert, Pump, Blood
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT (K854084) | Organon Teknika Corp. | 1985-11-08 |
Track FKL automatically
Every clearance here is in the API, with alerts when new ones post.