510(k) Report

FDA applicant

Sensomotoric Instruments, GmbH

Teltow, DE1 decision1997–19970 recalls

FDA records 1 decision for Sensomotoric Instruments, GmbH (Teltow, DE) in 1997: 1 510(k) clearance. All are in product code GWN (Nystagmograph). 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 Sensomotoric Instruments, GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sensomotoric Instruments, GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sensomotoric Instruments, GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GWNNystagmograph1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K9722432D Vog - Video-OculographySensomotoric Instruments, GmbH · 19973cite it

What has FDA decided for it lately?

  • K9722432D Vog - Video-OculographySensomotoric Instruments, GmbH · 1997

The one decision as Sensomotoric Instruments, GmbH →