FDA product code · General hospital

Pediatric/Child Facemask

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

OXZClass II21 CFR 878.4040510(k) required9 decisions since 20110 recalls

9 FDA decisions since 2011. 510(k) reviews decided 2021–2025 took a median of 418 days (half between 397 and 489). No recall names this code. The most-cited predicate is K160100, named by 3 later devices.

A pediatric/child facemask is intended to be worn by the patient/child to provide protection for the respiratory tract. It is a single use, disposable device that is provided non-sterile. The facemask is recommended for use in a healthcare setting with appropriate adult supervision.

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 OXZ 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 · OXZ

1in 2023

2007high 2 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OXZ

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

Recalls per year · OXZ

No recall names OXZ since 2007.

Adverse event reports per year · OXZ

1in 2023

2007high 1 (2023) · low 0 (2007)2025

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

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

Planning a device in OXZ? 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…FXP Cover, Shoe, Operating-Room

Pediatric/Child Facemask

Which predicates do OXZ devices cite most?

Which OXZ devices have the deepest lineage?

What has FDA decided in OXZ lately?

Related product codes