FDA product code · Gastroenterology and urology

Oral Removable Retainer For Weight Management

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

ONYClass II21 CFR 876.5981510(k) required2 decisions since 20160 recalls

2 FDA decisions since 2016. No recall names this code. The most-cited predicate is DEN150033, named by 1 later device.

A removable oral device used during meals to limit food intake.

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 ONY 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 · ONY

1in 2017

2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ONY

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

Recalls per year · ONY

No recall names ONY since 2007.

Adverse event reports per year · ONY

No MAUDE report names ONY since 2007.

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	1	—	0
2017	1	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

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

Planning a device in ONY? 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

Oral Removable Retainer For Weight Management

Which predicates do ONY devices cite most?

Which ONY devices have the deepest lineage?

What has FDA decided in ONY lately?