510(k) Report

FDA product code · Clinical toxicology

Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.

DPBClass II21 CFR 862.3320510(k) required10 decisions since 19760 recalls

10 FDA decisions since 1976. 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 DPB 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 · DPB

FDA has decided no DPB device since 2007.

Median 510(k) review, days · DPB

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

Recalls per year · DPB

No recall names DPB since 2007.

Adverse event reports per year · DPB

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

Planning a device in DPB? 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 862.3320.