510(k) · Cleared
ClearedEko Foundation Analysis Software with Transformers (EFAST)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eko Health, Inc. · DQD Stethoscope, Electronic
Cleared on Aug 12, 2025 as substantially equivalent to K213794 (Eko Devices, Inc., 2022) after an 89-day review. Its family tree reaches back 13 generations to 1991.
- Decided
- Aug 12, 2025
- Review
- 89 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K910772 (1991). 100 ancestors in all, the oldest K771653 (1977). No later device cites it as a predicate yet.
- Root · 13 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 9 generations between
- 3 generations backK131044 Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013
- 2 generations backK181988 eMurmur IDCsd Labs GmbH · 2019
- 1 generation backK213794 Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022
- This deviceK251494 Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc. · 2025
Show all 13 generations
- Root · 13 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 12 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 11 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 10 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 9 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 8 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 7 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 6 generations backK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- 5 generations backK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- 4 generations backK121617 SensicardiacDiacoustic Medical (Pty) · 2012
- 3 generations backK131044 Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013
- 2 generations backK181988 eMurmur IDCsd Labs GmbH · 2019
- 1 generation backK213794 Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022
- This deviceK251494 Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −12 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −11 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −10 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −9 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −8 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −7 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| −6 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| −5 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
| −4 | K121617 | Sensicardiac | Diacoustic Medical (Pty) | 2012 | — |
| −3 | K131044 | Sensicardiac Mobi Diagnostic Heart Murmur Application | Diacoustic Medical Devices (Pty), Ltd. | 2013 | — |
| −2 | K181988 | eMurmur ID | Csd Labs GmbH | 2019 | — |
| −1 | K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022 | — |
| 0 (this device) | K251494 | Eko Foundation Analysis Software with Transformers (EFAST) | Eko Health, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQD device
- #1 K200776 Eko COREscore 25.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K213794 | Eko Murmur Analysis Software (EMAS)Summary page 5…e Classification Name: Stethoscope Regulatory Class: Class II Product Code: DQD, DQC, DPS, MWI PREDICATE DEVICE Primary Predicate: Eko Murmur Analysis Software (EMAS, K213794) Reference Device: Eko Analysis Software (EAS, K192004) DEVICE DESCRIPTION Eko Foundation Analysis Software with Transformers… | 2022 |
| † | K192004 | Eko Analysis Software | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 34 years and passes through 9 companies; a new generation was cleared every 2.4 years on median.
- 4 of the 100 ancestors have a recall of any class.
- 1 other device also cites its predicate K213794.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DQD
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQD
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQD
No recall names DQD since 2007.
Adverse event reports per year · DQD
1in 2024
MAUDE reports naming product code DQD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 6 | 161 | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 107 | 0 | 1 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 5 | 70 | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 250 | 0 | 0 |
| 2017 | 4 | 109 | 0 | 0 |
| 2018 | 4 | 131 | 0 | 0 |
| 2019 | 4 | 262 | 0 | 0 |
| 2020 | 6 | 104 | 0 | 0 |
| 2021 | 4 | 137 | 0 | 0 |
| 2022 | 8 | 203 | 0 | 0 |
| 2023 | 10 | 132 | 0 | 0 |
| 2024 | 4 | 153 | 0 | 1 |
| 2025 | 3 | 89 | 0 | 0 |
| 2026 | 6 | 236 | 0 | — |
What is it indicated for?
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…
Read the full statement (145 words)
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).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251494: Eko Foundation Analysis Software with Transformers (EFAST).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251494
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026