510(k) · Cleared
ClearedEko Analysis Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eko Devices, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jan 15, 2020 as substantially equivalent to K170798 (Dictum Health, Inc., 2017) and 3 other predicates after a 173-day review. Its family tree reaches back 11 generations to 1991. 4 later devices descend from it.
- Decided
- Jan 15, 2020
- Review
- 173 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K910772 (1991). 97 ancestors in all, the oldest K771653 (1977). 4 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 7 generations between
- 3 generations backK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- 2 generations backK121617 SensicardiacDiacoustic Medical (Pty) · 2012
- 1 generation backK131044 Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013
- This deviceK192004 Eko Analysis SoftwareEko Devices, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK213794 Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK240901 StethophoneSparrow Acoustics, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK252595 Stethophone ProSparrow Acoustics, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK251494 Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 10 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 9 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 8 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 7 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 6 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 5 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 4 generations backK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
- 3 generations backK110704 SENSIDiacoustic Medical Devices (Pty), Ltd. · 2011
- 2 generations backK121617 SensicardiacDiacoustic Medical (Pty) · 2012
- 1 generation backK131044 Sensicardiac Mobi Diagnostic Heart Murmur ApplicationDiacoustic Medical Devices (Pty), Ltd. · 2013
- This deviceK192004 Eko Analysis SoftwareEko Devices, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc. · 2022 · cites it directly3descendants
- K240901StethophoneSparrow Acoustics, Inc. · 2024 · 2 generations on1descendant
- K252595Stethophone ProSparrow Acoustics, Inc. · 2025 · 3 generations on0descendants
- K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −10 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −9 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −8 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −7 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −6 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −5 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| −4 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 2009 | — |
| −3 | K110704 | SENSI | Diacoustic Medical Devices (Pty), Ltd. | 2011 | — |
| −2 | K121617 | Sensicardiac | Diacoustic Medical (Pty) | 2012 | — |
| −1 | K131044 | Sensicardiac Mobi Diagnostic Heart Murmur Application | Diacoustic Medical Devices (Pty), Ltd. | 2013 | — |
| 0 (this device) | K192004 | Eko Analysis Software | Eko Devices, Inc. | 2020 | — |
| +1 | K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022 | — |
| +2 | K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024 | — |
| +3 | K252595 | Stethophone Pro | Sparrow Acoustics, Inc. | 2025 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K170798 | Dictum HealthSummary page 4…Usual Name: CardiacAI Classification Name: Cardiac monitor Regulatory Class: Class II Product Code: MWI, DQD, DPS Predicate Devices Dictum Health Inc., IDM100 (K170798) Diacoustic Medical Devices (Pty) Ltd, SensiCardiac Mobi (K131044) Inovise Medical, AUDICOR 200 (K073545) ph… | 2017 |
| * | K131044 | Sensicardiac Mobi Diagnostic Heart Murmur ApplicationSummary page 4…ass: Class II Product Code: MWI, DQD, DPS Predicate Devices Dictum Health Inc., IDM100 (K170798) Diacoustic Medical Devices (Pty) Ltd, SensiCardiac Mobi (K131044) Inovise Medical, AUDICOR 200 (K073545) physIQ Inc, physIQ Heart Rhythm Module (K180234) Device Description… | 2013 |
| * | K073545 | Audicor, Hemo Ambulatory MonitorSummary page 4…dicate Devices Dictum Health Inc., IDM100 (K170798) Diacoustic Medical Devices (Pty) Ltd, SensiCardiac Mobi (K131044) Inovise Medical, AUDICOR 200 (K073545) physIQ Inc, physIQ Heart Rhythm Module (K180234) Device Description The Eko Analysis Software is a cloud-based s… | 2008 |
| * | K180234 | physiQ Heart Rhythm ModuleSummary page 4…98) Diacoustic Medical Devices (Pty) Ltd, SensiCardiac Mobi (K131044) Inovise Medical, AUDICOR 200 (K073545) physIQ Inc, physIQ Heart Rhythm Module (K180234) Device Description The Eko Analysis Software is a cloud-based software API that allows a user to upload synchron… | 2018 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213794 | Eko Murmur Analysis Software (EMAS) | 2022 | 3 |
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 29 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 4 of the 97 ancestors have a recall of any class.
- Of its descendants, K213794 (Eko Devices, Inc., 2022) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds and ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence of suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal sinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRS…
Read the full statement (131 words)
The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds and ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence of suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal sinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRS duration and EMAT. The software does not distinguish between different kinds of murmurs and does not identify other arrhythmias.
It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are only significant when used in conjunction with physician over-read and is for use on adults (> 18 years).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192004 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192004: Eko Analysis Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192004
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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