FDA product code · Immunology

System, Test, Systemic Lupus Erythematosus

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

DHCClass II21 CFR 866.5820510(k) required16 decisions since 19791 recall

16 FDA decisions since 1979. 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 DHC 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 · DHC

FDA has decided no DHC device since 2007.

Median 510(k) review, days · DHC

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

Recalls per year · DHC

1in 2009

2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DHC

No MAUDE report names DHC 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	—	1	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	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

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

Planning a device in DHC? 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

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System, Test, Systemic Lupus Erythematosus

What has FDA decided in DHC lately?

What has been recalled in DHC lately?

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