510(k) Report

FDA product code · Gastroenterology and urology

Dilator, Esophageal (Metal Olive) Gastro-Urology

EZMClass II21 CFR 876.5365510(k) exempt0 decisions0 recalls

FDA lists EZM 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. 0 FDA decisions. 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 EZM 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 · EZM

FDA has decided no EZM device since 2007.

Median 510(k) review, days · EZM

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

Recalls per year · EZM

No recall names EZM since 2007.

Adverse event reports per year · EZM

4in 2009

2009: 4
2007high 4 (2009) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—04
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 — EZM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in EZM? 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 876.5365.

FAT Bougie, Esophageal, And Gastrointestinal…PRQ Esophageal Dilator KitKNQ Dilator, Esophageal