510(k) Report

FDA product code · Microbiology

Reagents, Cysticercosis

MDJClass I21 CFR 866.3200510(k) exempt1 decision since 19900 recalls

FDA lists MDJ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1990. 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, microbiology panel

Twenty years of MDJ 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 · MDJ

FDA has decided no MDJ device since 2007.

Median 510(k) review, days · MDJ

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

Recalls per year · MDJ

No recall names MDJ since 2007.

Adverse event reports per year · MDJ

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

Planning a device in MDJ? 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 MDJ lately?

  • K900780Cysticercosis Serological ReagentsLmd Laboratories · 1990

The one MDJ decision →

Related product codes

Other codes under 21 CFR 866.3200.

GPE Antisera, Positive Control, Echinococcus Spp.GPD Antigen, Indirect Fluorescent Antibody Test…GPF Antigen, Agglutinating, Echinococcus Spp.