FII
5 FDA 510(k) clearances · Product code
117 daysmedian time to decision
153 days90th percentile
5clearances measured
FDA profile
- Official device name
- System, Dialysate Delivery, Sealed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 2005: 93 · 2006: 917 · 2007: 204 · 2008: 109 · 2009: 55 · 2010: 17
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 |
|---|---|---|
| NXSTAGE SYSTEM ONE (K030470) | Nxstage Medical, Inc. | 2003-07-07 |
| GAMBRO MULTIPURPOSE SYSTEM MPS-10 (K881270) | Gambro, Inc. | 1988-08-24 |
| HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (K872364) | Travenol Laboratories, S.A. | 1987-10-13 |
| HEMOFILTRATION SYSTEM 10 (K862716) | Gambro, Inc. | 1986-09-09 |
| COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA (K822386) | Hospal Medical Corp. | 1982-10-06 |
Track FII automatically
Every clearance here is in the API, with alerts when new ones post.