FDA product code · Neurology

Encephalogram Telemetry System

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

GYEClass II21 CFR 882.1855510(k) exempt20 decisions since 19760 recalls

FDA lists GYE 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. 20 FDA decisions since 1976. 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 GYE 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 · GYE

FDA has decided no GYE device since 2007.

Median 510(k) review, days · GYE

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

Recalls per year · GYE

No recall names GYE since 2007.

Adverse event reports per year · GYE

2in 2025

2007high 2 (2025) · low 0 (2007)2025

MAUDE reports naming product code GYE, 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	—	1
2010	—	1
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	—	2
2026	—	—

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

Planning a device in GYE? 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

Encephalogram Telemetry System

What has FDA decided in GYE lately?