510(k) Report

FDA product code · Gastroenterology and urology

Peritoneal Dialysate Filter

KPPClass II21 CFR 876.5630510(k) required3 decisions since 19800 recalls

3 FDA decisions since 1980. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, gastroenterology and urology panel

Twenty years of KPP at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · KPP

FDA has decided no KPP device since 2007.

Median 510(k) review, days · KPP

Too few KPP 510(k)s in any year since 2007 to give a median.

Recalls per year · KPP

No recall names KPP since 2007.

Adverse event reports per year · KPP

No MAUDE report names KPP since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — KPP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KPP? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

What has FDA decided in KPP lately?

  • K812615TM-CapdTri-Med, Inc. · 1982
  • K803275KPP Peritoneal Dialysate FilterMillipore Corp. · 1981
  • K800666Quik-TempLiquid Crystal Products, Inc. · 1980

All 3 KPP decisions →

Related product codes

Other codes under 21 CFR 876.5630.

PTU Catheter, Peritoneal, Long-Term Indwelling…FJS Catheter, Peritoneal, Long-Term IndwellingPPJ Peritoneal Dialysis Administration KitFKO Catheter, Peritoneal Dialysis, Single UseFKX System, Peritoneal, Automatic DeliveryPTW System, Peritoneal, Automatic Delivery, ExemptMLW Warmer, Peritoneal DialysatePPK Peritoneal Dialysis Tubing KitKDJ Set, Administration, For Peritoneal Dialysis…PTV Catheter, Peritoneal Dialysis, Single Use…PNG Peritoneal, Drainage Catheter For Refractory…KPF System, Dialysate Delivery, Semi-Automatic…