510(k) Report

FDA product code · Neurology

Transducer, Tremor

GYDClass II21 CFR 882.1950510(k) required15 decisions since 19790 recalls

15 FDA decisions since 1979. 510(k) reviews decided 2021–2025 took a median of 241 days (half between 219 and 263). No recall names this code. The most-cited predicate is K220820, named by 3 later devices.

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 GYD 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 · GYD

1in 2025

2007: 12014: 12016: 12022: 32023: 12025: 12026 (partial year): 3
2007high 3 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GYD

241in 2022

2022: 241 days median2026 (partial year): 190 days median
2007high 241 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GYD

No recall names GYD since 2007.

Adverse event reports per year · GYD

3in 2023

2023: 3
2007high 3 (2023) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20141—00
20150—00
20161—00
20170—00
20180—00
20190—00
20200—00
20210—00
2022324100
20231—03
20240—00
20251—00
202631900—
FIG. 1 — GYD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in GYD? 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