FDA product code · Gastroenterology and urology

System, Dialysate Delivery, Semi-Automatic, Peritoneal

Name: FDA decisions, review times, recalls and adverse event reports for product code KPF
Creator: 510(k) Report

KPFClass II21 CFR 876.5630510(k) required13 decisions since 19797 recalls

13 FDA decisions since 1979. 7 recalls name this code, 0 of them Class I. The most-cited predicate is K061515, named by 1 later device.

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 KPF 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 · KPF

FDA has decided no KPF device since 2007.

Median 510(k) review, days · KPF

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

Recalls per year · KPF

2in 2007

2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KPF

1in 2018

2007high 5 (2014) · low 0 (2008)2025

MAUDE reports naming product code KPF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	1
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	2
2012	—	0	0
2013	—	0	0
2014	—	0	5
2015	—	0	1
2016	—	0	0
2017	—	0	0
2018	—	0	1
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

FIG. 1 — KPF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in KPF? 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

Related product codes

Other codes under 21 CFR 876.5630.

PTU Catheter, Peritoneal, Long-Term Indwelling…FJS Catheter, Peritoneal, Long-Term Indwelling PPJ Peritoneal Dialysis Administration Kit FKO Catheter, Peritoneal Dialysis, Single Use FKX System, Peritoneal, Automatic Delivery PTW System, Peritoneal, Automatic Delivery, Exempt KPP Peritoneal Dialysate Filter MLW Warmer, Peritoneal Dialysate PPK Peritoneal Dialysis Tubing Kit KDJ Set, Administration, For Peritoneal Dialysis…PTV Catheter, Peritoneal Dialysis, Single Use…PNG Peritoneal, Drainage Catheter For Refractory…

System, Dialysate Delivery, Semi-Automatic, Peritoneal

Which predicates do KPF devices cite most?

Which KPF devices have the deepest lineage?

What has FDA decided in KPF lately?

What has been recalled in KPF lately?

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