FDA product code · Radiology

Synchronizer, Electrocardiograph, Nuclear

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

IYYClass I21 CFR 892.1410510(k) exempt3 decisions since 19780 recalls

FDA lists IYY 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. 3 FDA decisions since 1978. 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 IYY 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 · IYY

FDA has decided no IYY device since 2007.

Median 510(k) review, days · IYY

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

Recalls per year · IYY

No recall names IYY since 2007.

Adverse event reports per year · IYY

No MAUDE report names IYY 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 — IYY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in IYY? 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

Synchronizer, Electrocardiograph, Nuclear

What has FDA decided in IYY lately?