FDA product code · Neurology

Clamp, Carotid Artery

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

HCEClass II21 CFR 882.5175510(k) required2 decisions since 19810 recalls

2 FDA decisions since 1981. 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 HCE 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 · HCE

FDA has decided no HCE device since 2007.

Median 510(k) review, days · HCE

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

Recalls per year · HCE

No recall names HCE since 2007.

Adverse event reports per year · HCE

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

Planning a device in HCE? 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

Clamp, Carotid Artery

What has FDA decided in HCE lately?