FDA product code · Gastroenterology and urology

Rod, Colostomy

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

EZPClass II21 CFR 876.4270510(k) exempt2 decisions since 20040 recalls

FDA lists EZP 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. 2 FDA decisions since 2004. 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 EZP 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 · EZP

FDA has decided no EZP device since 2007.

Median 510(k) review, days · EZP

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

Recalls per year · EZP

No recall names EZP since 2007.

Adverse event reports per year · EZP

9in 2022

2007high 9 (2022) · low 0 (2007)2025

MAUDE reports naming product code EZP, 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	—	2
2013	—	2
2014	—	0
2015	—	0
2016	—	0
2017	—	1
2018	—	0
2019	—	1
2020	—	0
2021	—	0
2022	—	9
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in EZP? 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

Rod, Colostomy

Which EZP devices have the deepest lineage?

What has FDA decided in EZP lately?