FDA product code · Radiology

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

IYZClass I21 CFR 892.1350510(k) exempt12 decisions since 19890 recalls

FDA lists IYZ 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. 12 FDA decisions since 1989. No recall names this code.

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 IYZ 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 · IYZ

FDA has decided no IYZ device since 2007.

Median 510(k) review, days · IYZ

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

Recalls per year · IYZ

No recall names IYZ since 2007.

Adverse event reports per year · IYZ

No MAUDE report names IYZ since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in IYZ? 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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What has FDA decided in IYZ lately?