FDA product code · Radiology

Arthrogram Tray

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

OIIClass II21 CFR 892.1650510(k) exempt0 decisions3 recalls

FDA lists OII as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 892.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. 3 recalls name this code, 0 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, radiology panel

Twenty years of OII 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 · OII

FDA has decided no OII device since 2007.

Median 510(k) review, days · OII

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

Recalls per year · OII

3so far in 2026, the most since 2007

2007high 3 (2026) · low 0 (2007)2026

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

Adverse event reports per year · OII

1in 2023

2007high 2 (2020) · low 0 (2007)2025

MAUDE reports naming product code OII, 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	0
2019	—	0	1
2020	—	0	2
2021	—	0	0
2022	—	0	1
2023	—	0	1
2024	—	0	0
2025	—	0	0
2026	—	3	—

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

Planning a device in OII? 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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Arthrogram Tray

What has been recalled in OII lately?

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