510(k) Report

FDA product code · Ear, nose and throat

Oropharyngeal Electrical Stimulator

QQGClass II21 CFR 874.5950510(k) required1 decision since 20220 recalls

1 FDA decision since 2022. No recall names this code.

An oropharyngeal electrical stimulator is a device that stimulates afferent nerve fibers of oropharyngeal mucosa. The device is intended to treat swallowing dysfunction. The device may incorporate a feeding tube.

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, ear, nose and throat panel

Twenty years of QQG 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 · QQG

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QQG

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

Recalls per year · QQG

No recall names QQG since 2007.

Adverse event reports per year · QQG

2in 2025

2025: 2
2007high 2 (2025) · low 0 (2007)2025

MAUDE reports naming product code QQG, 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
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
20221—00
20230—00
20240—00
20250—02
20260—0—
FIG. 1 — QQG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in QQG? 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