510(k) Report

FDA applicant

Coala Life AB

Stockholm, SE2 decisions2019–20220 recalls

FDA records 2 decisions for Coala Life AB (Stockholm, SE) from 2019 to 2022: 2 510(k) clearances. Most are in product codes DXH (Transmitters And Receivers…) and DPS (Electrocardiograph). Its devices cite 3 predicates, 0 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 Coala Life AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2019: 12022: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Coala Life AB by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision
  • DPSElectrocardiograph1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K212163Coala Heart MonitorCoala Life AB · 2022
  • K182040Coala Heart MonitorCoala Life AB · 2019

All 2 as Coala Life AB →