FDA product code · Gastroenterology and urology

Garment, Protective, For Incontinence

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

EYQClass I21 CFR 876.5920510(k) exempt56 decisions since 19760 recalls

FDA lists EYQ 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. 56 FDA decisions since 1976. 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 EYQ 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 · EYQ

FDA has decided no EYQ device since 2007.

Median 510(k) review, days · EYQ

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

Recalls per year · EYQ

No recall names EYQ since 2007.

Adverse event reports per year · EYQ

5in 2025

2007high 28 (2019) · low 0 (2008)2025

MAUDE reports naming product code EYQ, 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	—	2
2008	—	0
2009	—	3
2010	—	3
2011	—	1
2012	—	9
2013	—	13
2014	—	11
2015	—	11
2016	—	6
2017	—	8
2018	—	20
2019	—	28
2020	—	4
2021	—	5
2022	—	5
2023	—	8
2024	—	7
2025	—	5
2026	—	—

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

Planning a device in EYQ? 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

Garment, Protective, For Incontinence

What has FDA decided in EYQ lately?