FDA applicant

Sunstar Suisse S.A.

Etoy, CH1 decision2017–20170 recalls

FDA records 1 decision for Sunstar Suisse S.A. (Etoy, CH) in 2017: 1 510(k) clearance. All are in product code HCC (Device, Biofeedback). 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 Sunstar Suisse S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Sunstar Suisse S.A. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sunstar Suisse S.A.’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

Other applicant names beginning “Sunstar”

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

Sunstar Americas, Inc. 3 Sunstar Butler 1

Sunstar Suisse S.A.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Sunstar”