FIF
6 FDA 510(k) clearances · Product code
61 daysmedian time to decision
97 days90th percentile
6clearances measured
FDA profile
- Official device name
- Set, Dialysis, Single Needle With Uni-Directional Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 2006: 2 · 2007: 3
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 |
|---|---|---|
| 8810 PUMP-PUMP SINGLE NEEDLE DEVICE (K873279) | Cd Medical, Inc. | 1987-10-23 |
| COBE SINGLE-NEEDLE CONTROLLER #18-756 (K820173) | Cobe Laboratories, Inc. | 1982-03-23 |
| BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP (K802230) | Cardio Med Supplies, Inc. | 1980-12-22 |
| MEDCOMP FEMORAL VEIN CATHETER (K801967) | Medical Components, Inc. | 1980-09-26 |
| MODEL DM 353 & DM-353-L SINGLE NEEDLE (K792174) | Extracorporeal Medical Specialities, Inc. | 1979-11-16 |
| GW 35 GUIDE WIRE (K772147) | Sorensen Research | 1977-11-28 |
Track FIF automatically
Every clearance here is in the API, with alerts when new ones post.