510(k) Report

FDA product code · Microbiology

Culture Media, Anaerobic Transport

JSLClass I21 CFR 866.2390510(k) required8 decisions since 19770 recalls

8 FDA decisions since 1977. No recall names this code. The most-cited predicate is K972448, named by 2 later devices.

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 JSL 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 · JSL

FDA has decided no JSL device since 2007.

Median 510(k) review, days · JSL

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

Recalls per year · JSL

No recall names JSL since 2007.

Adverse event reports per year · JSL

1in 2023

2007: 12008: 12009: 52012: 12013: 12014: 12018: 72019: 32020: 52021: 22022: 22023: 1
2007high 7 (2018) · low 0 (2010)2025

MAUDE reports naming product code JSL, 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—01
20080—01
20090—05
20100—00
20110—00
20120—01
20130—01
20140—01
20150—00
20160—00
20170—00
20180—07
20190—03
20200—05
20210—02
20220—02
20230—01
20240—00
20250—00
20260—0—
FIG. 1 — JSL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JSL? 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 866.2390.