510(k) Report

FDA product code · Microbiology

Culture Media, For Isolation Of Pathogenic Neisseria

JTYClass II21 CFR 866.2410510(k) required83 decisions since 19765 recalls

83 FDA decisions since 1976. 510(k) reviews decided 2021–2025 took a median of 239 days (half between 239 and 239). 5 recalls name this code, 0 of them Class I. The most-cited predicate is K993033, named by 1 later device.

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 JTY 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 · JTY

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JTY

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

Recalls per year · JTY

1in 2022

2022: 12026 (partial year): 1
2007high 1 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JTY

35in 2025

2021: 242022: 112023: 62024: 62025: 35
2007high 35 (2025) · low 0 (2007)2025

MAUDE reports naming product code JTY, 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—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20211—024
20220—111
20230—06
20240—06
20250—035
20260—1—
FIG. 1 — JTY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JTY? 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