FIL
8 FDA 510(k) clearances · Product code
57 daysmedian time to decision
413 days90th percentile
8clearances measured
FDA profile
- Official device name
- System, Dialysate Delivery, Single Pass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 2002: 30 · 2003: 5 · 2004: 4 · 2005: 5 · 2006: 3 · 2007: 2
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 |
|---|---|---|
| CRIT-LINE MONITOR III TQA (CLM TQA) (K011741) | Hemametrics | 2002-07-23 |
| SPS 550-IPS (INTEGRATED PATIENT STATION) (K901038) | Baxter Healthcare Corp | 1990-04-19 |
| FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM (K890329) | Fresenius USA, Inc. | 1989-05-11 |
| REPGREEN ULTRAFILTRATION MONITOR (K790824) | Cyberex Corp. | 1979-06-27 |
| ULTRAFILTRATION SCALE (K781633) | Extracorporeal Medical Specialities, Inc. | 1978-12-07 |
| ULTRAFILTRATION MONITOR 5M9034 (K771875) | Travenol Laboratories, S.A. | 1977-11-30 |
| AK-10 (K771227) | Gambro, Inc. | 1977-08-02 |
| NEGATIVE PRESSURE ADAPTER 5M1350 (K770137) | Travenol Laboratories, S.A. | 1977-02-01 |
Track FIL automatically
Every clearance here is in the API, with alerts when new ones post.