NFK
11 FDA 510(k) clearances · Product code
85 daysmedian time to decision
106 days90th percentile
11clearances measured
FDA profile
- Official device name
- Kit, Repair, Catheter, Hemodialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- FDA definition
- Hemodialysis Tray
- Adverse events (MAUDE)
- 2011: 16 · 2012: 11 · 2013: 16 · 2022: 18 · 2024: 19 · 2025: 19
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 |
|---|---|---|
| CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K101261) | C.R. Bard, Inc. | 2010-07-29 |
| ACUTE AND CHRONIC CATHETER REPAIR KIT (K092797) | Kendall | 2009-11-19 |
| CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K063446) | C.R. Bard, Inc. | 2006-12-15 |
| REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS (K062435) | Spire Biomedical, Inc. | 2006-12-05 |
| CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K030442) | C.R. Bard, Inc. | 2003-07-21 |
| RETRO REPAIR KIT, MODEL PRRK5 (K022644) | Spire Biomedical, Inc. | 2002-11-06 |
| MEDCOMP REPAIR KIT, MODEL ASPCRPK (K022570) | Medcomp | 2002-10-31 |
| CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K022561) | C.R. Bard, Inc. | 2002-08-23 |
| DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) (K020430) | Diatek, Inc. | 2002-05-09 |
| CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K011015) | C.R. Bard, Inc. | 2001-06-22 |
| MEDCOMP ASH SPLIT (K011576) | Medical Components, Inc. | 2001-06-21 |
Track NFK automatically
Every clearance here is in the API, with alerts when new ones post.