FDA product code · Immunology

Transferrin, Rhodamine, Antigen, Antiserum, Control

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

DDDClass II21 CFR 866.5880510(k) required1 decision since 19971 recall

1 FDA decision since 1997. 1 recall names this code; it is not Class I.

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 DDD 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 · DDD

FDA has decided no DDD device since 2007.

Median 510(k) review, days · DDD

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

Recalls per year · DDD

1in 2023

2007high 1 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DDD

No MAUDE report names DDD since 2007.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	1	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

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

Planning a device in DDD? 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 866.5880.

DDG Transferrin, Antigen, Antiserum, Control DDI Transferrin, Fitc, Antigen, Antiserum, Control JNM Immunochemical, Transferrin

Transferrin, Rhodamine, Antigen, Antiserum, Control

What has FDA decided in DDD lately?

What has been recalled in DDD lately?

Related product codes