510(k) Report

FDA applicant

Epi-Minder Pty, Ltd.

Melbourne, AU1 decision2025–20250 recalls

FDA records 1 decision for Epi-Minder Pty, Ltd. (Melbourne, AU) in 2025: 1 De Novo grant. All are in product code SEM (Sub-Scalp Implanted Electroencephalogram…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Epi-Minder Pty, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Epi-Minder Pty, Ltd. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Epi-Minder Pty, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • SEMSub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

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

What has FDA decided for it lately?

  • DEN240062Minder SystemEpi-Minder Pty, Ltd. · 2025

The one decision as Epi-Minder Pty, Ltd. →