FDA product code · General and plastic surgery

Dressing Change Tray

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

OXQClass I21 CFR 880.50750 decisions29 recalls

0 FDA decisions. 29 recalls name this code, 1 of them Class I.

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if…

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 and plastic surgery panel

Twenty years of OXQ 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 · OXQ

FDA has decided no OXQ device since 2007.

Median 510(k) review, days · OXQ

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

Recalls per year · OXQ

7in 2024

2007high 11 (2019) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · OXQ

10in 2025

2007high 55 (2021) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	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	1
2018	—	0	1
2019	—	11	1
2020	—	0	0
2021	—	0	55
2022	—	2	7
2023	—	1 (1)	6
2024	—	7	12
2025	—	0	10
2026	—	8	—

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

Planning a device in OXQ? 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

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Dressing Change Tray

What has been recalled in OXQ lately?

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