510(k) Report

FDA product code · Physical medicine

Twister, Brace Setting

ITOClass I21 CFR 890.3410510(k) exempt1 decision since 19800 recalls

FDA lists ITO 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 1980. 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 ITO 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 · ITO

FDA has decided no ITO device since 2007.

Median 510(k) review, days · ITO

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

Recalls per year · ITO

No recall names ITO since 2007.

Adverse event reports per year · ITO

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—01
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — ITO by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in ITO? 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

What has FDA decided in ITO lately?

  • K800716Orthotic Leg Gait Corrector DeviceIpos Luneburg · 1980

The one ITO decision →

Related product codes

Other codes under 21 CFR 890.3410.

ITC Stirrup, External Brace Component