510(k) Report

FDA applicant

Cardioline S.P.A

Cavareno, TN4 decisions2015–20231 recall

FDA records 4 decisions for Cardioline S.P.A (Cavareno, TN) from 2015 to 2023: 4 510(k) clearances. Most are in product codes DRG (Transmitters And Receivers, Physiological…) and DPS (Electrocardiograph). Since 2016 its 510(k)s took a median of 229 days from receipt to decision, against 229 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 1 of them its own earlier devices. 1 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 Cardioline S.P.A’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2015: 12016: 22023: 1
2015high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2015high 1 (2026) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Cardioline S.P.A by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency2decisions
  • DPSElectrocardiograph2decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 229 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 229 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K150289Cardioline HD+Cardioline S.P.A · 20153cite it

What has FDA decided for it lately?

  • K220526HD+12, HD+15Cardioline S.P.A · 20231 recall
  • K160746CARDIOLINE touchECGCardioline S.P.A · 2016
  • K160840ECG100+, ECG200+Cardioline S.P.A · 2016
  • K150289Cardioline HD+Cardioline S.P.A · 2015

All 4 as Cardioline S.P.A →

What has been recalled?

1 recall linked to its devices; the latest:

  • K220526Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version…Jul 20, 2026Class II