FDA product code · Immunology

Reagent, Complement

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

KTQClass I21 CFR 866.4100510(k) exempt6 decisions since 19790 recalls

FDA lists KTQ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 6 FDA decisions since 1979. 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, immunology panel

Twenty years of KTQ 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 · KTQ

FDA has decided no KTQ device since 2007.

Median 510(k) review, days · KTQ

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

Recalls per year · KTQ

No recall names KTQ since 2007.

Adverse event reports per year · KTQ

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

Planning a device in KTQ? 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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Reagent, Complement

What has FDA decided in KTQ lately?

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