510(k) Report

FDA product code · Clinical toxicology

Thin Layer Chromatography, Propoxyphene

DPNClass II21 CFR 862.3700510(k) required1 decision since 20040 recalls

1 FDA decision since 2004. 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 DPN 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 · DPN

FDA has decided no DPN device since 2007.

Median 510(k) review, days · DPN

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

Recalls per year · DPN

No recall names DPN since 2007.

Adverse event reports per year · DPN

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2025

MAUDE reports naming product code DPN, not matched to any one device; reports are not rates.

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—01
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 — DPN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DPN? 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

Related product codes

Other codes under 21 CFR 862.3700.