FDA product code KPP: Peritoneal Dialysate Filter
KPP is the FDA product code for peritoneal dialysate filter. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under KPP, from 3 different applicants. The average 510(k) review took 76 days (median 74).
Classification
| Field | Value |
|---|---|
| Device name | Peritoneal Dialysate Filter |
| Device class | Class II |
| Regulation | 21 CFR 876.5630 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every KPP clearance
Top KPP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tri-Med, Inc. | 1 | 1982-01-05 |
| Millipore Corp. | 1 | 1981-03-13 |
| Liquid Crystal Products, Inc. | 1 | 1980-05-08 |
Most recent KPP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K812615 | Tri-Med, Inc. | TM-CAPD | 1982-01-05 | 112 |
| K803275 | Millipore Corp. | KPP PERITONEAL DIALYSATE FILTER | 1981-03-13 | 74 |
| K800666 | Liquid Crystal Products, Inc. | QUIK-TEMP | 1980-05-08 | 43 |
Recalls for KPP devices
openFDA lists no recalls for product code KPP.
Frequently asked questions
What is FDA product code KPP?
KPP is the FDA product code for peritoneal dialysate filter. It is a Class II device, regulated under 21 CFR 876.5630 and reviewed by the Gastroenterology and Urology panel.
What device class is KPP?
Class II, regulation 21 CFR 876.5630. Typical premarket route: 510(k).
How long does a 510(k) take for product code KPP?
Across 3 cleared submissions the average was 76 days from receipt to decision (median 74).
Which companies have the most KPP clearances?
Tri-Med, Inc. (1); Millipore Corp. (1); Liquid Crystal Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KPP
- Run a recall and safety report across every KPP manufacturer
- Watch product code KPP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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