FDA product code · Immunology

Lipoprotein X, Antigen, Antiserum, Control

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

DELClass I21 CFR 866.5590510(k) exempt5 decisions since 19890 recalls

FDA lists DEL 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. 5 FDA decisions since 1989. 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, immunology panel

Twenty years of DEL 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 · DEL

FDA has decided no DEL device since 2007.

Median 510(k) review, days · DEL

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

Recalls per year · DEL

No recall names DEL since 2007.

Adverse event reports per year · DEL

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

Planning a device in DEL? 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

Lipoprotein X, Antigen, Antiserum, Control

Which DEL devices have the deepest lineage?

What has FDA decided in DEL lately?