510(k) · Cleared
ClearedEko CORE
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 Apr 6, 2020 as substantially equivalent to K151319 (Eko Devices, Inc., 2015) and 1 other predicate after a 12-day review. Its family tree reaches back 8 generations to 1996. 13 later devices descend from it.
- Decided
- Apr 6, 2020
- Review
- 12 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K952882 (1996). 23 ancestors in all, the oldest K771653 (1977). 13 later devices descend from it, 8 citing it directly.
- Root · 8 generations backK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
- 7 generations backK964554 Personal Telemedicine ModuleAmerican Telecare, Inc. · 1996
- 6 generations backK973873 Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc. · 1997
- 5 generations backK034046 RNK Telephonic Stethoscope, Model TR-1Rnk Products · 2004
- 4 generations backK072026 RNK Electronic StethoscopeRnk Products, Inc. · 2007
- 3 generations backK102893 PCP/PC StethoscopeRnk Products, Inc. · 2011
- 2 generations backK160401 Tyto StethoscopeTyto Care, Ltd. · 2016
- 1 generation backK181612 Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018
- This deviceK200776 Eko COREEko Devices, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK231551 StethophoneSparrow Acoustics, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK210736 doctorgram Stethoscope DES-IGv Concepts · 2021
- Descendant · 2 generations on · 1 of its ownK240901 StethophoneSparrow Acoustics, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK212975 MedWandMedwand Solutions, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK220470 Smart Wireless StethoscopeShanghai Hulu Devices Co., Ltd. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K231551StethophoneSparrow Acoustics, Inc. · 2023 · cites it directly2descendants
- K210736doctorgram Stethoscope DES-IGv Concepts · 2021 · cites it directly2descendants
- K240901StethophoneSparrow Acoustics, Inc. · 2024 · 2 generations on1descendant
- K212975MedWandMedwand Solutions, Inc. · 2022 · 2 generations on1descendant
- K220470Smart Wireless StethoscopeShanghai Hulu Devices Co., Ltd. · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K952882 | Personal Telemedicine System | American Telecare, Inc. | 1996 | — |
| −7 | K964554 | Personal Telemedicine Module | American Telecare, Inc. | 1996 | — |
| −6 | K973873 | Digital Personal Telemedicine Module, Digital PTM 1 | American Telecare, Inc. | 1997 | — |
| −5 | K034046 | RNK Telephonic Stethoscope, Model TR-1 | Rnk Products | 2004 | — |
| −4 | K072026 | RNK Electronic Stethoscope | Rnk Products, Inc. | 2007 | — |
| −3 | K102893 | PCP/PC Stethoscope | Rnk Products, Inc. | 2011 | — |
| −2 | K160401 | Tyto Stethoscope | Tyto Care, Ltd. | 2016 | — |
| −1 | K181612 | Tyto Stethoscope (OTC) | Tyto Care, Ltd. | 2018 | — |
| 0 (this device) | K200776 | Eko CORE | Eko Devices, Inc. | 2020 | — |
| +1 | K231551 | Stethophone | Sparrow Acoustics, Inc. | 2023 | — |
| +1 | K210736 | doctorgram Stethoscope DES-I | Gv Concepts | 2021 | — |
| +2 | K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024 | — |
| +2 | K212975 | MedWand | Medwand Solutions, Inc. | 2022 | — |
| +1 | K220470 | Smart Wireless Stethoscope | Shanghai Hulu Devices Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 K240901 Stethophonescore 14.6 · 13 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…tethoscope Classification Name: Electronic Stethoscope Regulatory Class: Class II Product Code: DQD, 870.1875 Predicate Devices: Eko Electronic Stethoscope System (EESS)(K151319), Eko Devices, Inc. Tyto Stethoscope (K181612) (OTC), Tyto Care Ltd. Device Description The Eko CORE (… | 2015 |
| * | K181612 | Tyto Stethoscope (OTC)Summary page 4…Class: Class II Product Code: DQD, 870.1875 Predicate Devices: Eko Electronic Stethoscope System (EESS)(K151319), Eko Devices, Inc. Tyto Stethoscope (K181612) (OTC), Tyto Care Ltd. Device Description The Eko CORE (OTC) is a digital stethoscope device designed for use by health c… | 2018 |
What descends from it? (13)
See all 138 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?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K231551 (Sparrow Acoustics, Inc., 2023) has gone furthest, with 2 descendants of its own.
- 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 Eko CORE is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data (heart, lungs, bowel, arteries, and veins), whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. Eko CORE is intended for use on pediatric and adult patients. The Eko CORE is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200776: Eko CORE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200776
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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