FDA product code · Dental

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

KCQClass I21 CFR 872.6570510(k) exempt1 decision since 19900 recalls

FDA lists KCQ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 872.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1990. 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, dental panel

Twenty years of KCQ 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 · KCQ

FDA has decided no KCQ device since 2007.

Median 510(k) review, days · KCQ

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

Recalls per year · KCQ

No recall names KCQ since 2007.

Adverse event reports per year · KCQ

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

Planning a device in KCQ? 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

Tube Impression And Matrix

What has FDA decided in KCQ lately?