510(k) · Cleared
ClearedeKuore One Wireless Electronic Interface for stethoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chip Ideas Electronics S.L. · DQD Stethoscope, Electronic
Cleared on Nov 24, 2020 as substantially equivalent to K151319 (Eko Devices, Inc., 2015) and 1 other predicate after a 152-day review. Its family tree reaches back 2 generations to 2015.
- Decided
- Nov 24, 2020
- Review
- 152 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K151319 (2015). No later device cites it as a predicate yet.
- Root · 2 generations backK151319 Eko Electronic Stethoscope SystemEko Devices, Inc. · 2015
- 1 generation backK181882 eKuore One electronic interface for stethoscopeChip Ideas Electronics S.L. · 2019
- This deviceK201742 eKuore One Wireless Electronic Interface for stethoscopeChip Ideas Electronics S.L. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K151319 | Eko Electronic Stethoscope System | Eko Devices, Inc. | 2015 | — |
| −1 | K181882 | eKuore One electronic interface for stethoscope | Chip Ideas Electronics S.L. | 2019 | — |
| 0 (this device) | K201742 | eKuore One Wireless Electronic Interface for stethoscope | Chip Ideas Electronics S.L. | 2020 | — |
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? (2)
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 |
|---|---|---|---|
| * | K151319 | Eko Electronic Stethoscope SystemSummary page 4…Class II Product Code: DQD Regulation Number: 870.1875 PREDICATE DEVICE Predicate Device (S): Eko Electronic Stethoscope System, K151319 Page 1 of 7… | 2015 |
| * | K181882 | eKuore One electronic interface for stethoscopeSummary page 6…tation into a mobile device. In the establishment of substantial equivalence, eKuore One Wireless electronic interface for stethoscopes compared to the predicate device K181882 eKuore One electronic interface for stethoscope and the reference device K151319 Eko Electronic Stethoscope System: Elements o… | 2019 |
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 5 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K151319.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 eKuore One Wireless electronic interface for stethoscope is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore One Wireless is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to the accompanying mobile software application.
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.
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/K201742 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201742: eKuore One Wireless Electronic Interface for stethoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201742
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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