510(k) Report

FDA applicant

Coroventis Research AB

Uppsala, SE2 decisions2020–20250 recalls

FDA records 2 decisions for Coroventis Research AB (Uppsala, SE) from 2020 to 2025: 2 510(k) clearances. All are in product code DQK (Computer, Diagnostic, Programmable). Its devices cite 5 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 Coroventis Research AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020: 12025: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Coroventis Research AB by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQKComputer, Diagnostic, Programmable2decisions

Whose devices does it build on?

Its devices cite 5 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.

  • K201881CoroFlow Cardiovascular SystemCoroventis Research AB · 20201cites it

What has FDA decided for it lately?

  • K252238CoroFlow Cardiovascular SystemCoroventis Research AB · 2025
  • K201881CoroFlow Cardiovascular SystemCoroventis Research AB · 2020

All 2 as Coroventis Research AB →