510(k) Report

FDA product code · Neurology

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

NHLClass IIIPMA required1 decision since 20020 recalls

1 FDA decision since 2002. No recall names this code.

Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinsons disease that are not adequately controlled with medication.

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 NHL 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 · NHL

10in 2025

2015: 12017: 12018: 62019: 172020: 112021: 82022: 62023: 122024: 142025: 102026 (partial year): 10
2007high 17 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHL

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

Recalls per year · NHL

No recall names NHL since 2007.

Adverse event reports per year · NHL

197in 2025

2012: 12017: 32018: 662019: 742020: 1462021: 2052022: 2142023: 4112024: 3962025: 197
2007high 411 (2023) · low 0 (2007)2025

MAUDE reports naming product code NHL, 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—01
20130—00
20140—00
20151—00
20160—00
20171—03
20186—066
201917—074
202011—0146
20218—0205
20226—0214
202312—0411
202414—0396
202510—0197
202610—0—
FIG. 1 — NHL by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NHL? 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