FDA product code · Ear, nose and throat

Device, Anti-Stammering

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

KTHClass I21 CFR 874.5840510(k) exempt4 decisions since 19800 recalls

FDA lists KTH 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. 4 FDA decisions since 1980. 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 KTH 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 · KTH

FDA has decided no KTH device since 2007.

Median 510(k) review, days · KTH

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

Recalls per year · KTH

No recall names KTH since 2007.

Adverse event reports per year · KTH

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

Planning a device in KTH? 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

Device, Anti-Stammering

What has FDA decided in KTH lately?