510(k) Report

FDA product code · Clinical toxicology

Solution, M-Nitrophenol, Specific Reagent For Cholinesterase

DMRClass I21 CFR 862.3240510(k) exempt1 decision since 19790 recalls

FDA lists DMR 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 1979. 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 DMR 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 · DMR

FDA has decided no DMR device since 2007.

Median 510(k) review, days · DMR

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

Recalls per year · DMR

No recall names DMR since 2007.

Adverse event reports per year · DMR

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

Planning a device in DMR? 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 DMR lately?

  • K790986RF ControlsWampole Laboratories · 1979

The one DMR decision →

Related product codes

Other codes under 21 CFR 862.3240.

DIH Colorimetry, CholinesteraseDOH Electrometry, CholinesteraseDLI Acetylcholine Chloride, Specific Reagent For…DIG Cholinesterase Test Paper