FDA product code · Physical medicine

Splint, Abduction, Congenital Hip Dislocation

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

IOZClass I21 CFR 890.3665510(k) exempt4 decisions since 19780 recalls

FDA lists IOZ 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. 4 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, physical medicine panel

Twenty years of IOZ 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 · IOZ

FDA has decided no IOZ device since 2007.

Median 510(k) review, days · IOZ

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

Recalls per year · IOZ

No recall names IOZ since 2007.

Adverse event reports per year · IOZ

1in 2015

2007high 1 (2015) · low 0 (2007)2025

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

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	—	1
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in IOZ? 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

Splint, Abduction, Congenital Hip Dislocation

What has FDA decided in IOZ lately?