KPP
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Peritoneal Dialysate Filter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5630
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 1994: 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 |
|---|---|---|
| TM-CAPD (K812615) | Tri-Med, Inc. | 1982-01-05 |
| KPP PERITONEAL DIALYSATE FILTER (K803275) | Millipore Corp. | 1981-03-13 |
| QUIK-TEMP (K800666) | Liquid Crystal Products, Inc. | 1980-05-08 |
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Every clearance here is in the API, with alerts when new ones post.