510(k) Report

FDA product code · Microbiology

Transport Systems, Anaerobic

JTXClass I21 CFR 866.2900510(k) required8 decisions since 19760 recalls

8 FDA decisions since 1976. 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 JTX 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 · JTX

FDA has decided no JTX device since 2007.

Median 510(k) review, days · JTX

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

Recalls per year · JTX

No recall names JTX since 2007.

Adverse event reports per year · JTX

1in 2021

2011: 12012: 52014: 12021: 1
2007high 5 (2012) · low 0 (2007)2025

MAUDE reports naming product code JTX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—01
20120—05
20130—00
20140—01
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — JTX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JTX? 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

Related product codes

Other codes under 21 CFR 866.2900.