FDA applicant

Path Medical GmbH

Germering, DE6 decisions2010–20225 recalls

FDA records 6 decisions for Path Medical GmbH (Germering, DE) from 2010 to 2022: 6 510(k) clearances. Most are in product codes GWJ (Stimulator, Auditory, Evoked Response) and EWO (Audiometer). Its devices cite 10 predicates, 2 of them its own earlier devices. 5 recalls are 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 Path Medical GmbH’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2010high 2 (2022) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2025

2010high 4 (2023) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Path Medical GmbH by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Other applicant names beginning “Path”

FDA records each applicant name separately; these may or may not be the same firm.

Path Scientific, LLC 1

Path Medical GmbH

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Path”