FKY
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Connector, Tubing, Dialysate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 1994: 3 · 2008: 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 |
|---|---|---|
| PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI (K991003) | Dayspring Medical, Inc. | 1999-06-09 |
| TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE (K862722) | Mercury Enterprises, Inc. | 1986-08-11 |
| CAPD COLOR-GUARD SYSTEM PREPKIT (K830002) | Abbott Laboratories | 1983-03-11 |
| TENCKHOFF PERITONEAL TUBING ADAPT. (K771428) | Quinton, Inc. | 1977-10-18 |
Track FKY automatically
Every clearance here is in the API, with alerts when new ones post.