FDA product code · Neurology

Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache

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

OKPClass II21 CFR 882.5808510(k) required6 decisions since 20130 recalls

6 FDA decisions since 2013. 510(k) reviews decided 2021–2025 took a median of 95 days (half between 95 and 95). No recall names this code. The most-cited predicate is K140094, named by 2 later devices.

Transcranial magnetic stimulator for the treatment of migraine headache delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric currents for the treatment of migraine headache.

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, neurology panel

Twenty years of OKP 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 · OKP

1in 2023

2007high 1 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OKP

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

Recalls per year · OKP

No recall names OKP since 2007.

Adverse event reports per year · OKP

1in 2024

2007high 2 (2019) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	1	—	0
2014	1	—	0
2015	0	—	0
2016	1	—	0
2017	1	—	0
2018	0	—	0
2019	1	—	2
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	1	—	0
2024	0	—	1
2025	0	—	0
2026	0	—	—

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

Planning a device in OKP? 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

Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache

Which predicates do OKP devices cite most?

Which OKP devices have the deepest lineage?

What has FDA decided in OKP lately?