FDA product code · Ear, nose and throat

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

ETKClass I21 CFR 874.1925510(k) exempt1 decision since 19830 recalls

FDA lists ETK 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 1983. 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 ETK 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 · ETK

FDA has decided no ETK device since 2007.

Median 510(k) review, days · ETK

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

Recalls per year · ETK

No recall names ETK since 2007.

Adverse event reports per year · ETK

No MAUDE report names ETK 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 — ETK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in ETK? 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

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What has FDA decided in ETK lately?