510(k) Report

FDA applicant

Eko Devices, Inc.

Berkeley, CA6 decisions2015–20230 recalls

FDA records 6 decisions for Eko Devices, Inc. (Berkeley, CA) from 2015 to 2023: 6 510(k) clearances. Most are in product codes DQD (Stethoscope, Electronic) and MWI (Monitor, Physiological, Patient (Without…). Since 2016 its 510(k)s took a median of 129 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 3 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 Eko Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2015: 12017: 12020: 22022: 12023: 1
2015high 2 (2020) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Eko Devices, Inc. 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?

  • DQDStethoscope, Electronic5decisions
  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 129 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 132 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 3 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.

  • K200776Eko COREEko Devices, Inc. · 20208cite it
  • K151319Eko Electronic Stethoscope SystemEko Devices, Inc. · 20154cite it
  • K170874Eko Model E5 System (EME5), Eko DUOEko Devices, Inc. · 20173cite it
  • K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 20222cite it
  • K230111CORE 500 Digital StethoscopeEko Devices, Inc. · 20231cites it
  • K192004Eko Analysis SoftwareEko Devices, Inc. · 20201cites it

What has FDA decided for it lately?

  • K230111CORE 500 Digital StethoscopeEko Devices, Inc. · 2023
  • K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022
  • K200776Eko COREEko Devices, Inc. · 2020
  • K192004Eko Analysis SoftwareEko Devices, Inc. · 2020
  • K170874Eko Model E5 System (EME5), Eko DUOEko Devices, Inc. · 2017
  • K151319Eko Electronic Stethoscope SystemEko Devices, Inc. · 2015

All 6 as Eko Devices, Inc. →