FDA product code · General hospital

Medical Device Data System

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

OUGClass I21 CFR 880.6310510(k) exempt1 decision since 201310 recalls

FDA lists OUG as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 880.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2013. 10 recalls name this code, 0 of them Class I.

A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a…

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, general hospital panel

Twenty years of OUG 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 · OUG

1in 2013

2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OUG

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

Recalls per year · OUG

1in 2021

2007high 2 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OUG

393in 2025

2007high 1,249 (2023) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	1	7
2012	0	—	0	23
2013	1	—	0	21
2014	0	—	2	24
2015	0	—	0	13
2016	0	—	2	20
2017	0	—	0	17
2018	0	—	0	414
2019	0	—	2	46
2020	0	—	2	29
2021	0	—	1	79
2022	0	—	0	50
2023	0	—	0	1,249
2024	0	—	0	554
2025	0	—	0	393
2026	0	—	0	—

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

Planning a device in OUG? 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

Medical Device Data System

Which OUG devices have the deepest lineage?

What has FDA decided in OUG lately?

What has been recalled in OUG lately?