FDA product code · Microbiology

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

JTQClass I21 CFR 866.2540510(k) exempt12 decisions since 19770 recalls

FDA lists JTQ 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. 12 FDA decisions since 1977. 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, microbiology panel

Twenty years of JTQ 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 · JTQ

FDA has decided no JTQ device since 2007.

Median 510(k) review, days · JTQ

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

Recalls per year · JTQ

No recall names JTQ since 2007.

Adverse event reports per year · JTQ

2in 2025

2007high 4 (2007) · low 0 (2011)2025

MAUDE reports naming product code JTQ, 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	—	4
2008	—	1
2009	—	1
2010	—	1
2011	—	0
2012	—	3
2013	—	1
2014	—	0
2015	—	4
2016	—	1
2017	—	0
2018	—	0
2019	—	2
2020	—	2
2021	—	0
2022	—	0
2023	—	1
2024	—	0
2025	—	2
2026	—	—

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

Planning a device in JTQ? 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 JTQ lately?