Peritoneal Dialysate Filter
This device is a peritoneal dialysate filter used to remove particulates and contaminants from dialysate solution before it enters the peritoneal cavity during peritoneal dialysis. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPP, regulated under 21 CFR 876.5630 within the Gastroenterology and Urology specialty. This device carries a life-sustaining or life-supporting designation due to its role in dialysis therapy.
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Basic Information
- Product Code
- KPP
- Device Class
- FDA class 2
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K812615 | TM-CAPD | Jan 05, 1982 | Substantially Equivalent | Tri-Med, Inc. |
| K803275 | KPP PERITONEAL DIALYSATE FILTER | Mar 13, 1981 | Substantially Equivalent | Millipore Corp. |
| K800666 | QUIK-TEMP | May 08, 1980 | Substantially Equivalent | Liquid Crystal Products, Inc. |