510(k) · Cleared
ClearedEko Model E5 System (EME5), Eko DUO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eko Devices, Inc. · DQD Stethoscope, Electronic
Cleared on May 19, 2017 after a 56-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- May 19, 2017
- Review
- 56 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK170874 Eko Model E5 System (EME5), Eko DUOEko Devices, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK230111 CORE 500 Digital StethoscopeEko Devices, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK193518 KosmosEchoNous, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK233609 CORE 500 Digital StethoscopeEko Health, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK212100 KosmosEchoNous, Inc. · 2021 · Recalled
- Descendant · cites it directly · 0 of its ownK182040 Coala Heart MonitorCoala Life AB · 2019
Most influential descendants
Showing 5 of 5 · See all- K230111CORE 500 Digital StethoscopeEko Devices, Inc. · 2023 · cites it directly1descendant
- K193518KosmosEchoNous, Inc. · 2020 · cites it directly1descendant
- K233609CORE 500 Digital StethoscopeEko Health, Inc. · 2024 · 2 generations on0descendants
- K212100KosmosEchoNous, Inc. · 2021 · 2 generations on0descendants
- K182040Coala Heart MonitorCoala Life AB · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K170874 | Eko Model E5 System (EME5), Eko DUO | Eko Devices, Inc. | 2017 | — |
| +1 | K230111 | CORE 500 Digital Stethoscope | Eko Devices, Inc. | 2023 | — |
| +1 | K193518 | Kosmos | EchoNous, Inc. | 2020 | — |
| +2 | K233609 | CORE 500 Digital Stethoscope | Eko Health, Inc. | 2024 | — |
| +2 | K212100 | Kosmos | EchoNous, Inc. | 2021 | 1 |
| +1 | K182040 | Coala Heart Monitor | Coala Life AB | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K230111 (Eko Devices, Inc., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Model E5 System is intended to be used by healthcare professionals to electronically amplify, filter, and transfer body sounds and single-channel electrocardiogram (ECG) waveforms. The Eko Model E5 System also displays ECG waveforms and phonocardiogram waveforms on the accompanying mobile application for storage and sharing (when prescribed or used under the care of a physician). It can be used to record heart sounds and cardiac murmurs, bruits…
Read the full statement (141 words)
The Eko Model E5 System is intended to be used by healthcare professionals to electronically amplify, filter, and transfer body sounds and single-channel electrocardiogram (ECG) waveforms. The Eko Model E5 System also displays ECG waveforms and phonocardiogram waveforms on the accompanying mobile application for storage and sharing (when prescribed or used under the care of a physician). It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds, and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary, or abdominal organ systems. The device can be used on adults and pediatrics.
The data offered by the device is only significant when used in conjunction with physician over read as well as consideration of other relevant patient data.
The device should not be used on infants weighing less than 10kg.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K170874 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170874: Eko Model E5 System (EME5), Eko DUO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170874
Report an extraction error
Are you the manufacturer?
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