510(k) Report

FDA product code · Clinical chemistry

Colorimetric, Mucopolysaccharides

JQNClass I21 CFR 862.1505510(k) exempt2 decisions since 19800 recalls

FDA lists JQN 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. 2 FDA decisions since 1980. 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 JQN 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 · JQN

FDA has decided no JQN device since 2007.

Median 510(k) review, days · JQN

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

Recalls per year · JQN

No recall names JQN since 2007.

Adverse event reports per year · JQN

No MAUDE report names JQN 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 — JQN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JQN? 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 JQN lately?

  • K863070Fast MucoproteinsJ. D. Assoc. · 1986
  • K792554Elvi MucaproteinsVolu Sol Medical Industries · 1980

All 2 JQN decisions →

Related product codes

Other codes under 21 CFR 862.1505.

MPG Urinary Carbohydrate Analysis Kit