FDA product code · Physical medicine

Unit, Chilling

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

IMFClass I21 CFR 890.5940510(k) exempt2 decisions since 19870 recalls

FDA lists IMF 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. 2 FDA decisions since 1987. 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 IMF 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 · IMF

FDA has decided no IMF device since 2007.

Median 510(k) review, days · IMF

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

Recalls per year · IMF

No recall names IMF since 2007.

Adverse event reports per year · IMF

1in 2008

2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code IMF, 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	—	1
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 — IMF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in IMF? 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

Unit, Chilling

What has FDA decided in IMF lately?