510(k) Report

FDA product code · Neurology

Stimulator, Electrical, Implanted, For Essential Tremor

PJSClass IIIPMA required0 decisions since 20210 recalls

0 FDA decisions since 2021. No recall names this code.

Deep Brain Stimulation for the treatment of essential tremor

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 PJS 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 · PJS

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PJS

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

Recalls per year · PJS

No recall names PJS since 2007.

Adverse event reports per year · PJS

423in 2025

2016: 12019: 22020: 152021: 2022022: 2942023: 5432024: 4932025: 423
2007high 543 (2023) · low 0 (2007)2025

MAUDE reports naming product code PJS, 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—01
20170—00
20180—00
20190—02
20200—015
20211—0202
20220—0294
20230—0543
20240—0493
20250—0423
20260—0—
FIG. 1 — PJS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PJS? 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