FDA product code · Neurology

Stimulator, Functional Walking Neuromuscular, Non-Invasive

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

MKDClass IIIPMA required1 decision since 19940 recalls

1 FDA decision since 1994. 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, neurology panel

Twenty years of MKD 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 · MKD

FDA has decided no MKD device since 2007.

Median 510(k) review, days · MKD

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

Recalls per year · MKD

No recall names MKD since 2007.

Adverse event reports per year · MKD

5in 2014

2007high 5 (2014) · low 0 (2007)2025

MAUDE reports naming product code MKD, 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	—	5
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 — MKD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MKD? 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

Stimulator, Functional Walking Neuromuscular, Non-Invasive

What has FDA decided in MKD lately?