510(k) Report

FDA product code · Clinical chemistry

Nad Reduction (U.V.), Phosphohexose Isomerase

KLJClass I21 CFR 862.1570510(k) exempt1 decision since 19770 recalls

FDA lists KLJ 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 1977. 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 KLJ 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 · KLJ

FDA has decided no KLJ device since 2007.

Median 510(k) review, days · KLJ

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

Recalls per year · KLJ

No recall names KLJ since 2007.

Adverse event reports per year · KLJ

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

Planning a device in KLJ? 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 KLJ lately?

  • K770577Deter. of Phosphohexose IsomeraseSigma Chemical Co. · 1977

The one KLJ decision →

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Other codes under 21 CFR 862.1570.

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