FDA applicant

Sunrise SA

Namur, BE3 decisions2022–20250 recalls

FDA records 3 decisions for Sunrise SA (Namur, BE) from 2022 to 2025: 2 510(k) clearances and 1 De Novo grant. All are in product code QRS (Device For Sleep Apnea Testing Based On…). Its devices cite 2 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Sunrise”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Sunrise SA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Sunrise SA by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sunrise SA’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 “Sunrise”

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

Sunrise Medical, Inc. 33 Sunrise Technologies, Inc. 19 Sunrise Medical Hhg, Inc. 10 Sunrise Medical (Us), LLC 5 Sunrise Medical Quickie Designs, Inc. 4 Sunrise International Business 1

Sunrise SA

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Sunrise”