510(k) Report

FDA product code · Gastroenterology and urology

Catheter, Upper Urinary Tract

EYCClass II21 CFR 876.5130510(k) required5 decisions since 19890 recalls

5 FDA decisions since 1989. No recall names this code. The most-cited predicate is K041416, named by 2 later devices.

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 EYC 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 · EYC

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EYC

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

Recalls per year · EYC

No recall names EYC since 2007.

Adverse event reports per year · EYC

15in 2025

2013: 12014: 12015: 12016: 72017: 12018: 32019: 32020: 62021: 62024: 262025: 15
2007high 26 (2024) · low 0 (2007)2025

MAUDE reports naming product code EYC, 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—00
20100—00
20110—00
20120—00
20130—01
20140—01
20150—01
20160—07
20170—01
20180—03
20190—03
20201—06
20210—06
20220—00
20230—00
20240—026
20250—015
20260—0—
FIG. 1 — EYC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in EYC? 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 876.5130.