FDA product code · Pathology

Lambda, Peroxidase, Antigen, Antiserum, Control

Name: FDA decisions, review times, recalls and adverse event reports for product code DEP
Creator: 510(k) Report

DEPClass II21 CFR 866.5550510(k) required1 decision since 19800 recalls

1 FDA decision since 1980. 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, pathology panel

Twenty years of DEP 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 · DEP

FDA has decided no DEP device since 2007.

Median 510(k) review, days · DEP

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

Recalls per year · DEP

No recall names DEP since 2007.

Adverse event reports per year · DEP

No MAUDE report names DEP since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — DEP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DEP? 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 866.5550.

Lambda, Peroxidase, Antigen, Antiserum, Control

What has FDA decided in DEP lately?

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