FDA product code · Neurology

Stimulator, Autonomic Nerve, Implanted (Depression)

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

MUZClass IIIPMA required0 decisions since 20050 recalls

0 FDA decisions since 2005. No recall names this code.

The device is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

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 MUZ 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 · MUZ

4in 2016

2007high 13 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUZ

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

Recalls per year · MUZ

No recall names MUZ since 2007.

Adverse event reports per year · MUZ

56in 2025

2007high 278 (2008) · low 54 (2017)2025

MAUDE reports naming product code MUZ, 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	—	263
2008	0	—	278
2009	0	—	178
2010	0	—	130
2011	2	—	151
2012	10	—	125
2013	13	—	90
2014	6	—	99
2015	12	—	102
2016	4	—	78
2017	0	—	54
2018	0	—	73
2019	0	—	84
2020	0	—	74
2021	0	—	103
2022	0	—	105
2023	0	—	116
2024	0	—	78
2025	0	—	56
2026	0	—	—

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

Planning a device in MUZ? 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