FDA product code · Physical medicine

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

IKOClass II21 CFR 890.1450510(k) exempt1 decision since 19900 recalls

FDA lists IKO as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 890.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1990. 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, physical medicine panel

Twenty years of IKO 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 · IKO

FDA has decided no IKO device since 2007.

Median 510(k) review, days · IKO

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

Recalls per year · IKO

No recall names IKO since 2007.

Adverse event reports per year · IKO

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

Planning a device in IKO? 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 IKO lately?