FDA product code · Gastroenterology and urology

Catheter, Rectal For Continent Ileostomy

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

KPHClass I21 CFR 876.5030510(k) exempt1 decision since 19810 recalls

FDA lists KPH as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 876.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1981. 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 KPH 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 · KPH

FDA has decided no KPH device since 2007.

Median 510(k) review, days · KPH

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

Recalls per year · KPH

No recall names KPH since 2007.

Adverse event reports per year · KPH

1in 2018

2007high 1 (2015) · low 0 (2007)2025

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

View these four charts as a table

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

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

Planning a device in KPH? 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

Catheter, Rectal For Continent Ileostomy

What has FDA decided in KPH lately?