FID
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tubing, Dialysate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 2003: 1 · 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 |
|---|---|---|
| TUBING, DIALYSATE (AND CONNECTOR) (K022068) | Molded Products, Inc. | 2002-09-23 |
| DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES (K010712) | Molded Products, Inc. | 2001-09-27 |
| TYGON M-60/TYGON M-70 (K770299) | Norton Performance Plastics Corp. | 1977-03-16 |
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Every clearance here is in the API, with alerts when new ones post.