FKJ
5 FDA 510(k) clearances · Product code
78 daysmedian time to decision
149 days90th percentile
5clearances measured
FDA profile
- Official device name
- Filter, Blood, Dialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 2007: 7 · 2008: 3 · 2009: 3 · 2010: 4 · 2016: 48 · 2017: 11
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 |
|---|---|---|
| GUARDIAN™ Quick Dip Residual Chlorine (5212) (K253863) | Serim Research | 2026-03-17 |
| SERIM RESIDUAL CHLORINE TEST KIT (K901734) | Serim Research Corp. | 1990-09-13 |
| BBL GASPAK POUCH (K841307) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-05-14 |
| J.E.T. DIALYSIS SYSTEM (K820575) | Computer Dialysis Systems, Inc. | 1982-05-20 |
| TRANSDUCER PROTECTOR (K772040) | Terumo America, Inc. | 1977-11-28 |
Track FKJ automatically
Every clearance here is in the API, with alerts when new ones post.