FDA product code · Neurology

Electrode, Stabilized Epidural Spinal

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

LHYClass IIIPMA required1 decision since 19820 recalls

1 FDA decision since 1982. 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 LHY 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 · LHY

FDA has decided no LHY device since 2007.

Median 510(k) review, days · LHY

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

Recalls per year · LHY

No recall names LHY since 2007.

Adverse event reports per year · LHY

1in 2007

2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code LHY, 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	—	1
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 — LHY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in LHY? 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

Electrode, Stabilized Epidural Spinal

What has FDA decided in LHY lately?