510(k) Report

FDA product code · Clinical toxicology

Antiserum, Gentamicin

DJIClass II21 CFR 862.3450510(k) required1 decision since 19810 recalls

1 FDA decision since 1981. 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 DJI 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 · DJI

FDA has decided no DJI device since 2007.

Median 510(k) review, days · DJI

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

Recalls per year · DJI

No recall names DJI since 2007.

Adverse event reports per year · DJI

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

Planning a device in DJI? 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 DJI lately?

  • K812050Kallestad Antisera to GentamicinKallestad Laboratories, Inc. · 1981

The one DJI decision →

Related product codes

Other codes under 21 CFR 862.3450.

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