FDA product code · Ear, nose and throat

Mold, Middle-Ear

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

ETCClass II21 CFR 874.3430510(k) exempt1 decision since 19930 recalls

FDA lists ETC as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 874.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1993. 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, ear, nose and throat panel

Twenty years of ETC 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 · ETC

FDA has decided no ETC device since 2007.

Median 510(k) review, days · ETC

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

Recalls per year · ETC

No recall names ETC since 2007.

Adverse event reports per year · ETC

No MAUDE report names ETC since 2007.

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	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in ETC? 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

Mold, Middle-Ear

What has FDA decided in ETC lately?