FDA product code · Dental

Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

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

QNOClass II21 CFR 872.5575510(k) required3 decisions since 20210 recalls

3 FDA decisions since 2021. 510(k) reviews decided 2021–2025 took a median of 83 days (half between 73 and 92). No recall names this code. The most-cited predicate is K223446, named by 1 later device.

A neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea consists of a removable intraoral mouthpiece that uses electrodes to deliver neuromuscular stimulation to the tongue to strengthen tongue musculature to reduce snoring and obstructive sleep apnea.

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, dental panel

Twenty years of QNO 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 · QNO

1in 2024

2007high 1 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QNO

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

Recalls per year · QNO

No recall names QNO since 2007.

Adverse event reports per year · QNO

1in 2025

2007high 3 (2021) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	1	—	3
2022	0	—	3
2023	1	—	3
2024	1	—	0
2025	0	—	1
2026	0	—	—

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

Planning a device in QNO? 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

Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

Which predicates do QNO devices cite most?

Which QNO devices have the deepest lineage?

What has FDA decided in QNO lately?