FDA product code · Neurology

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

HADClass II21 CFR 882.4845510(k) required3 decisions since 19910 recalls

3 FDA decisions since 1991. No recall names this code. The most-cited predicate is K022907, named by 1 later device.

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, neurology panel

Twenty years of HAD 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 · HAD

FDA has decided no HAD device since 2007.

Median 510(k) review, days · HAD

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

Recalls per year · HAD

No recall names HAD since 2007.

Adverse event reports per year · HAD

1in 2022

2007high 15 (2015) · low 0 (2007)2025

MAUDE reports naming product code HAD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	2
2012	—	0
2013	—	1
2014	—	1
2015	—	15
2016	—	10
2017	—	4
2018	—	4
2019	—	0
2020	—	1
2021	—	1
2022	—	1
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in HAD? 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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Which predicates do HAD devices cite most?

Which HAD devices have the deepest lineage?

What has FDA decided in HAD lately?