FDA product code · Physical medicine

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

KTCClass I21 CFR 890.5125510(k) exempt7 decisions since 19800 recalls

FDA lists KTC as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 890.9 applies, such as a new intended use or a different fundamental technology. 7 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, physical medicine panel

Twenty years of KTC 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 · KTC

FDA has decided no KTC device since 2007.

Median 510(k) review, days · KTC

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

Recalls per year · KTC

No recall names KTC since 2007.

Adverse event reports per year · KTC

1in 2022

2007high 76 (2015) · low 0 (2007)2025

MAUDE reports naming product code KTC, 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	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	1
2014	—	3
2015	—	76
2016	—	19
2017	—	0
2018	—	0
2019	—	1
2020	—	0
2021	—	0
2022	—	1
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in KTC? 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

Bath, Sitz, Nonpowered

What has FDA decided in KTC lately?