FDA.reportPublic FDA data

EFAST (Eko Foundation Analysis Software with Transformers)

Primary DI
00810209880040
Brand
EFAST (Eko Foundation Analysis Software with Transformers)
Company
Eko Health, Inc.
Model
1.x.x
Catalog number
EFAST
Device description
The Eko Foundation Analysis Software with Transformers (EFAST) is intended to support healthcare professionals in the evaluation of patients’ heart sounds and electrocardiograms (ECGs). The software calculates heart rate, detects the presence of murmurs associated with Structural Heart Disease, and determines murmur timing including the timing of S1, S2 heart sounds. When ECG is available, the software detects the presence of atrial fibrillation and normal sinus rhythm. The software is intended for use by or under the supervision of a healthcare professional and is not to be used as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are designed to support and not replace the healthcare professional’s clinical judgment. The murmur detection is intended for use on both pediatric and adult patients, while the detection of atrial fibrillation is intended for use on adults (> 18 years).
Published
2026-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph
DQCPhonocardiograph
DQDStethoscope, Electronic
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DQCPhonocardiographCardiovascular1
DQDStethoscope, ElectronicCardiovascular2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251494000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251494000Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.2025-08-12DQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810209880040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810209880040008102098800408102098800400810209880040

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary physiological parameter analysis software, professional-onlyA software program designed to add image processing and/or data analysis capabilities to a computer/workstation for the interpretation and/or screening of cardiopulmonary physiological parameters [e.g., electrocardiogram (ECG), blood pressure, vital capacity (VC)]; data may be uploaded, or collected in real-time by connection (e.g., wired, Bluetooth) to other devices for spot-checks and/or continuous monitoring. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiopulmonary events [e.g., acute myocardial infarction (AMI)] or screen for specific conditions (e.g., low ejection fraction). It might include machine learning (ML) technology.

Regulatory Flags#

DUNS number
079670921
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceE82026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoE82026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedE82026-10-01
00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceE82026-10-01
00810209880217CORE 300™ Digital Stethoscope - BlackE102026-10-01
00810209880224CORE 300™ Digital Stethoscope - BerryE102026-10-01
00810209880231CORE 300™ Digital Stethoscope - SunsetE102026-10-01
00810209880248CORE 300™ Digital Stethoscope - PacificE102026-10-01
00810209880255CORE 300™ Digital Stethoscope - CloudE102026-10-01
00810209880057CORE 500 Digital Stethoscope - Navy Blue EarpieceE8CAC500_ENB2026-06-12
00810209880064CORE 500 Digital Stethoscope - Military Green EarpieceE8CAC500_EMG2026-06-12
00810209880071CORE 500 Digital Stethoscope - Navy Blue BundleE8COR501-SLV/ENB2026-06-12
00810209880088CORE 500 Digital Stethoscope - Military Green BundleE8COR501-BLK/EMG2026-06-12
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkE8CAC500_FRP2026-04-03
00810209880026CORE 500 Digital Stethoscope FIGS Earpiece - Orange TaffyE8CAC500_FOT2026-04-03
00850010298740CORE 500 Digital Stethoscope - Ruby ChestpieceE8COR500_RED2025-10-15
00850010298894CORE 500 Digital Stethoscope - Cool Blue ChestpieceE8COR500_CBL2025-11-07
00850010298900CORE 500 Digital Stethoscope - Cool Blue EarpieceE8CAC500_CBL2025-11-07
00850010298917CORE 500 Digital Stethoscope FIGS Earpiece - ElderberryE8CAC500_FEL2025-10-15
00850010298924CORE 500 Digital Stethoscope FIGS Earpiece - Off WhiteE8CAC500_FOW2025-10-15

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Primary DI, Brand, Company table
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00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDPS2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDPS2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDPS2026-10-04
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceEko Health, Inc.DPS2026-10-01
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceEko Health, Inc.DQD2026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoEko Health, Inc.DPS2026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoEko Health, Inc.DQD2026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedEko Health, Inc.DPS2026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedEko Health, Inc.DQD2026-10-01
00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceEko Health, Inc.DQD2026-10-01
00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceEko Health, Inc.DPS2026-10-01
00810209880217CORE 300™ Digital Stethoscope - BlackEko Health, Inc.DQD2026-10-01
00810209880224CORE 300™ Digital Stethoscope - BerryEko Health, Inc.DQD2026-10-01
00810209880231CORE 300™ Digital Stethoscope - SunsetEko Health, Inc.DQD2026-10-01
00810209880248CORE 300™ Digital Stethoscope - PacificEko Health, Inc.DQD2026-10-01
00810209880255CORE 300™ Digital Stethoscope - CloudEko Health, Inc.DQD2026-10-01
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