510(k) Report

FDA applicant

Corsano Health B.V.

S'-Gravenhage, NL2 decisions2024–20260 recalls

FDA records 2 decisions for Corsano Health B.V. (S'-Gravenhage, NL) from 2024 to 2026: 2 510(k) clearances. All are in product code MSX (System, Network And Communication…). Its devices cite 2 predicates, 1 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, cardiovascular panel, where it files most

How often FDA has decided Corsano Health B.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 12026 (partial year): 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Corsano Health B.V. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MSXSystem, Network And Communication, Physiological Monitors2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V. · 20241cites it

What has FDA decided for it lately?

  • K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V. · 2026
  • K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V. · 2024

All 2 as Corsano Health B.V. →