FDA product code · General hospital

Surgical Mask With Antimicrobial/Antiviral Agent

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

OUKClass II21 CFR 878.4040510(k) required4 decisions since 20110 recalls

4 FDA decisions since 2011. 510(k) reviews decided 2021–2025 took a median of 449 days (half between 449 and 449). No recall names this code. The most-cited predicate is K101128, named by 3 later devices.

A single use, disposable surgical mask for occupational use to cover the nose and mouth of the wearer to protect from the transfer of microorganisms,body fluids and particulates and has an added antimicrobial and/or antiviral agent which kills specific pathogens under specified contact conditions.

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 OUK 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 · OUK

1in 2024

2007high 2 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OUK

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

Recalls per year · OUK

No recall names OUK since 2007.

Adverse event reports per year · OUK

1in 2017

2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code OUK, 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	1	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	1
2018	0	—	0
2019	2	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	1	—	0
2025	0	—	0
2026	0	—	—

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

Planning a device in OUK? 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

Related product codes

Other codes under 21 CFR 878.4040.

FXZ Helmet, Surgical LYU Accessory, Surgical Apparel OKF Body Fluid Disposal Kit FYE Dress, Surgical FXW Shoes, Operating-Room OKG Body Fluid Clean Up Kit BWP Shoe And Shoe Cover, Conductive FXO Suit, Surgical FYA Gown, Surgical MSH Respirator, Surgical QSO Medical Gowns With Chemotherapy Labeling…OXZ Pediatric/Child Facemask

Surgical Mask With Antimicrobial/Antiviral Agent

Which predicates do OUK devices cite most?

Which OUK devices have the deepest lineage?

What has FDA decided in OUK lately?

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