FDA product code · Microbiology

Plasma, Coagulase, Human, Horse And Rabbit

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

JTLClass I21 CFR 866.2160510(k) exempt12 decisions since 19790 recalls

FDA lists JTL 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 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, microbiology panel

Twenty years of JTL 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 · JTL

FDA has decided no JTL device since 2007.

Median 510(k) review, days · JTL

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

Recalls per year · JTL

No recall names JTL since 2007.

Adverse event reports per year · JTL

2in 2021

2007high 2 (2021) · low 0 (2007)2025

MAUDE reports naming product code JTL, 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	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	2
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in JTL? 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

Plasma, Coagulase, Human, Horse And Rabbit

What has FDA decided in JTL lately?