510(k) Report

FDA applicant

Cardiacsense

Caesarea, IL2 decisions2023–20240 recalls

FDA records 2 decisions for Cardiacsense (Caesarea, IL) from 2023 to 2024: 2 510(k) clearances. All are in product code DPS (Electrocardiograph). Its devices cite 3 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 Cardiacsense’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023: 12024: 1
2023high 1 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Cardiacsense by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardiacsense’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

Which product codes does it file in?

  • DPSElectrocardiograph2decisions

Whose devices does it build on?

Its devices cite 3 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.

  • K221260CSF-3Cardiacsense · 20231cites it

What has FDA decided for it lately?

  • K232445CSF-4 (CSF-4)Cardiacsense · 2024
  • K221260CSF-3Cardiacsense · 2023

All 2 as Cardiacsense →