FDA product code · Neurology

Device, Skin Potential Measurement

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

HCJClass II21 CFR 882.1560510(k) exempt2 decisions since 19830 recalls

FDA lists HCJ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 882.9 applies, such as a new intended use or a different fundamental technology. 2 FDA decisions 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, neurology panel

Twenty years of HCJ 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 · HCJ

FDA has decided no HCJ device since 2007.

Median 510(k) review, days · HCJ

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

Recalls per year · HCJ

No recall names HCJ since 2007.

Adverse event reports per year · HCJ

1in 2024

2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code HCJ, 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	—	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	—	1
2025	—	0
2026	—	—

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

Planning a device in HCJ? 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

Device, Skin Potential Measurement

What has FDA decided in HCJ lately?