510(k) Report

FDA product code · Clinical chemistry

Colorimetric, Xylose

JOCClass I21 CFR 862.1820510(k) exempt1 decision since 19990 recalls

FDA lists JOC as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1999. 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, clinical chemistry panel

Twenty years of JOC 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 · JOC

FDA has decided no JOC device since 2007.

Median 510(k) review, days · JOC

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

Recalls per year · JOC

No recall names JOC since 2007.

Adverse event reports per year · JOC

No MAUDE report names JOC since 2007.

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
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — JOC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JOC? 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

What has FDA decided in JOC lately?

  • K991156Great Smokies Intestinal Permability Test SystemGreat Smokies Diagnostic Laboratory · 1999

The one JOC decision →

Related product codes

Other codes under 21 CFR 862.1820.

JQM P-Bromoaniline, XyloseNRH System, Breath Measurement