FDA product code · Immunology

Fibrinopeptide A, Antigen, Antiserum, Control

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

DANClass II21 CFR 866.5350510(k) required3 decisions since 19820 recalls

3 FDA decisions since 1982. 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 DAN 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 · DAN

FDA has decided no DAN device since 2007.

Median 510(k) review, days · DAN

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

Recalls per year · DAN

No recall names DAN since 2007.

Adverse event reports per year · DAN

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

Planning a device in DAN? 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

Fibrinopeptide A, Antigen, Antiserum, Control

What has FDA decided in DAN lately?