Eko Murmur Analysis Software (EMAS)

K213794

Eko Devices, Inc. · cleared 2022-06-29 · product code DQD · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Eko Murmur Analysis Software (EMAS) is a cloud-based service that allows users to upload heart sound/phonocardiogram (PCG) and optional electrocardiogram (ECG) data via an application programming interface (API) for analysis. The software uses signal processing (such as waveform filtering), as well as algorithms derived from machine learning, to analyze the acquired data and generate clinical decision support output for clinicians.”
Algorithmalgorithms derived from machine learning
source quote (p.4)
“The software uses signal processing (such as waveform filtering), as well as algorithms derived from machine learning, to analyze the acquired data and generate clinical decision support output for clinicians.”
Adaptive (vs locked)No
source quote (p.8)
“All algorithm testing was performed once the final EMAS version was locked.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=615 patients

endpoints: Murmur Classification

standards: FDA's General Principles of Software Validation; Final Guidance for Industry and FDA Staff issued May 11, 2005

Retrospective clinical

n=299 cases

endpoints: S1 Detection; S2 Detection

standards: FDA's General Principles of Software Validation; Final Guidance for Industry and FDA Staff issued May 11, 2005

Reported performance (6 observations)

sensitivity85.6CI 82.6 - 88.7
source quote (p.8)
“85.6 (95% CI: 82.6 - 88.7)”
specificity84.4CI 81.3 - 87.5
source quote (p.8)
“84.4 (95% CI: 81.3 - 87.5)”
sensitivityas written: “S1 Detection Sensitivity”96.2CI 94.9 - 97.4
source quote (p.9)
“96.2 (95% CI: 94.9 - 97.4)”
ppvas written: “S1 Detection PPV”97.1CI 96.3 - 98.0
source quote (p.9)
“97.1 (95% CI: 96.3 - 98.0)”
sensitivityas written: “S2 Detection Sensitivity”92.3CI 90.3 - 94.3
source quote (p.9)
“92.3 (95% CI: 90.3 - 94.3)”
ppvas written: “S2 Detection PPV”94.3CI 93.4 - 95.1
source quote (p.9)
“94.3 (95% CI: 93.4 - 95.1)”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
1
MAUDE reports in code, 12mo
+200%
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K213794