FDA product code · Microbiology

Anaerobic Box Glove

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

JTMClass I21 CFR 866.2120510(k) exempt1 decision since 19800 recalls

FDA lists JTM 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. 1 FDA decision 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, microbiology panel

Twenty years of JTM 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 · JTM

FDA has decided no JTM device since 2007.

Median 510(k) review, days · JTM

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

Recalls per year · JTM

No recall names JTM since 2007.

Adverse event reports per year · JTM

1in 2016

2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code JTM, 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	—	0
2014	—	0
2015	—	0
2016	—	1
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in JTM? 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

Anaerobic Box Glove

What has FDA decided in JTM lately?