510(k) Report

FDA product code · Neurology

Stimulator, Thalamic, Epilepsy, Implanted

MBXClass IIIPathway set case by case0 decisions since 20180 recalls

0 FDA decisions since 2018. 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 MBX 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 · MBX

1in 2024

2018: 12022: 12023: 12024: 1
2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBX

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

Recalls per year · MBX

No recall names MBX since 2007.

Adverse event reports per year · MBX

83in 2025

2018: 82019: 322020: 182021: 362022: 442023: 622024: 732025: 83
2007high 83 (2025) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20181—08
20190—032
20200—018
20210—036
20221—044
20231—062
20241—073
20250—083
20260—0—
FIG. 1 — MBX by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MBX? 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