510(k) Report

FDA applicant

Megin OY

Espoo, FI1 decision2024–20240 recalls

FDA records 1 decision for Megin OY (Espoo, FI) in 2024: 1 510(k) clearance. All are in product code OLX (Source Localization Software For…). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Megin OY’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Megin OY by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Megin OY’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?

  • OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

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.

  • K233985TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OY · 20241cites it

What has FDA decided for it lately?

  • K233985TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OY · 2024

The one decision as Megin OY →