FKB
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Connector, Blood Tubing, Infusion T
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 1994: 5 · 1995: 3 · 2000: 1 · 2001: 2 · 2003: 3 · 2005: 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 |
|---|---|---|
| DC-4 SHUNT INFUSION T (K891754) | Akcess Medical Products, Inc. | 1989-04-07 |
| PEDIATRIC INFUSION T (K771426) | Quinton, Inc. | 1977-12-20 |
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Every clearance here is in the API, with alerts when new ones post.