510(k) Report

FDA product code · Neurology

Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

SEMClass II21 CFR 882.1360510(k) required2 decisions since 20250 recalls

2 FDA decisions since 2025. No recall names this code. The most-cited predicate is DEN240062, named by 1 later device.

A sub-scalp implanted electroencephalogram (EEG) system for remote patient monitoring is a prescription device used for continuously acquiring, transmitting, and storing electrical brain activity of patients with epilepsy. The device consists of sub-scalp implanted electrodes that are connected to a transmitter or storage device. The device is used to aid clinicians in the remote monitoring of electrical activity…

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 SEM 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 · SEM

1in 2025

2025: 12026 (partial year): 1
2007high 1 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SEM

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

Recalls per year · SEM

No recall names SEM since 2007.

Adverse event reports per year · SEM

No MAUDE report names SEM since 2007.

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
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20251—00
20261—0—
FIG. 1 — SEM by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in SEM? 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

Which predicates do SEM devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • DEN240062Minder SystemEpi-Minder Pty, Ltd. · 20251cites it

Which SEM devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K253607UNEEG EpiSight SystemUneeg Medical A/S · 20261generation

What has FDA decided in SEM lately?

  • K253607UNEEG EpiSight SystemUneeg Medical A/S · 2026
  • DEN240062Minder SystemEpi-Minder Pty, Ltd. · 2025

All 2 SEM decisions →