FDA product code · Physical medicine

Device, Warning, Overload, External Limb, Powered

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

IRNClass II21 CFR 890.5575510(k) exempt11 decisions since 19770 recalls

FDA lists IRN 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. 11 FDA decisions since 1977. No recall names this code. The most-cited predicate is K882974, named by 2 later devices.

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 IRN 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 · IRN

FDA has decided no IRN device since 2007.

Median 510(k) review, days · IRN

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

Recalls per year · IRN

No recall names IRN since 2007.

Adverse event reports per year · IRN

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

Planning a device in IRN? 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

Device, Warning, Overload, External Limb, Powered

Which predicates do IRN devices cite most?

Which IRN devices have the deepest lineage?

What has FDA decided in IRN lately?