510(k) Report

FDA product code · Clinical toxicology

Cholinesterase Test Paper

DIGClass I21 CFR 862.3240510(k) exempt1 decision since 20030 recalls

FDA lists DIG 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 2003. 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 toxicology panel

Twenty years of DIG 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 · DIG

FDA has decided no DIG device since 2007.

Median 510(k) review, days · DIG

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

Recalls per year · DIG

No recall names DIG since 2007.

Adverse event reports per year · DIG

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

Planning a device in DIG? 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 DIG lately?

  • K024339Cozart Eia Opiates Oral Fluid KitCozart Bioscience, Ltd. · 2003

The one DIG decision →

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