FDA product code · Immunology

Igm, Fitc, Antigen, Antiserum, Control

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

DFSClass II21 CFR 866.5550510(k) required1 decision since 19830 recalls

1 FDA decision since 1983. 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 DFS 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 · DFS

FDA has decided no DFS device since 2007.

Median 510(k) review, days · DFS

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

Recalls per year · DFS

No recall names DFS since 2007.

Adverse event reports per year · DFS

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

Planning a device in DFS? 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.

Igm, Fitc, Antigen, Antiserum, Control

What has FDA decided in DFS lately?

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