510(k) Report

FDA product code · Gastroenterology and urology

System, Electrogastrography (Egg)

MYEClass II21 CFR 876.1735510(k) required9 decisions since 19990 recalls

9 FDA decisions since 1999. 510(k) reviews decided 2021–2025 took a median of 118 days (half between 96 and 157). No recall names this code. The most-cited predicate is DEN990005, 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, gastroenterology and urology panel

Twenty years of MYE 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 · MYE

1in 2025

2022: 22023: 22024: 12025: 12026 (partial year): 1
2007high 2 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MYE

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

Recalls per year · MYE

No recall names MYE since 2007.

Adverse event reports per year · MYE

No MAUDE report names MYE since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20222—00
20232—00
20241—00
20251—00
20261—0—
FIG. 1 — MYE by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MYE? 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