510(k) Report

FDA applicant

Ait Austrian Institute of Technology GmbH

Vienna, AT2 decisions2018–20240 recalls

FDA records 2 decisions for Ait Austrian Institute of Technology GmbH (Vienna, AT) from 2018 to 2024: 2 510(k) clearances. All are in product code OMB (Automatic Event Detection Software For…). Its devices cite 6 predicates, 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 Ait Austrian Institute of Technology GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2018: 12024: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Ait Austrian Institute of Technology GmbH by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph2decisions

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 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.

  • K171720encevisAit Austrian Institute of Technology GmbH · 20183cite it
  • K240993encevis (2.1)Ait Austrian Institute of Technology GmbH · 20242cite it

What has FDA decided for it lately?

  • K240993encevis (2.1)Ait Austrian Institute of Technology GmbH · 2024
  • K171720encevisAit Austrian Institute of Technology GmbH · 2018

All 2 as Ait Austrian Institute of Technology GmbH →