510(k) · Cleared
ClearedCORE 300 Digital Stethoscope
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 Jul 23, 2026 as substantially equivalent to K200776 (Eko Devices, Inc., 2020) after a 62-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Jul 23, 2026
- Review
- 62 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K952882 (1996). 24 ancestors in all, the oldest K771653 (1977). No later device cites it as a predicate yet.
- Root · 9 generations backK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
- 5 generations between
- 3 generations backK160401 Tyto StethoscopeTyto Care, Ltd. · 2016
- 2 generations backK181612 Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018
- 1 generation backK200776 Eko COREEko Devices, Inc. · 2020
- This deviceK261694 CORE 300 Digital StethoscopeEko Health, Inc. · 2026
Show all 9 generations
- Root · 9 generations backK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
- 8 generations backK964554 Personal Telemedicine ModuleAmerican Telecare, Inc. · 1996
- 7 generations backK973873 Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc. · 1997
- 6 generations backK034046 RNK Telephonic Stethoscope, Model TR-1Rnk Products · 2004
- 5 generations backK072026 RNK Electronic StethoscopeRnk Products, Inc. · 2007
- 4 generations backK102893 PCP/PC StethoscopeRnk Products, Inc. · 2011
- 3 generations backK160401 Tyto StethoscopeTyto Care, Ltd. · 2016
- 2 generations backK181612 Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018
- 1 generation backK200776 Eko COREEko Devices, Inc. · 2020
- This deviceK261694 CORE 300 Digital StethoscopeEko Health, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K952882 | Personal Telemedicine System | American Telecare, Inc. | 1996 | — |
| −8 | K964554 | Personal Telemedicine Module | American Telecare, Inc. | 1996 | — |
| −7 | K973873 | Digital Personal Telemedicine Module, Digital PTM 1 | American Telecare, Inc. | 1997 | — |
| −6 | K034046 | RNK Telephonic Stethoscope, Model TR-1 | Rnk Products | 2004 | — |
| −5 | K072026 | RNK Electronic Stethoscope | Rnk Products, Inc. | 2007 | — |
| −4 | K102893 | PCP/PC Stethoscope | Rnk Products, Inc. | 2011 | — |
| −3 | K160401 | Tyto Stethoscope | Tyto Care, Ltd. | 2016 | — |
| −2 | K181612 | Tyto Stethoscope (OTC) | Tyto Care, Ltd. | 2018 | — |
| −1 | K200776 | Eko CORE | Eko Devices, Inc. | 2020 | — |
| 0 (this device) | K261694 | CORE 300 Digital Stethoscope | Eko Health, Inc. | 2026 | — |
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 |
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 |
|---|---|---|---|
| * | K200776 | Eko CORESummary page 5…on number: 21 CFR 870.1875 Device Classification Name: Electronic Stethoscope Regulatory Class: Class II Product Code: DQD PREDICATE DEVICE Predicate Device: Eko CORE (K200776) Reference Device: CORE 500 Digital Stethoscope (K233609) DEVICE DESCRIPTION The CORE 300 Digital Stethoscope (CORE 300) is an… | 2020 |
| † | K233609 | CORE 500 Digital Stethoscope | 2024 |
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 30 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- None of the 24 ancestors has a recall.
- 7 other devices also cite its predicate K200776.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 CORE 300 Digital Stethoscope is intended to electronically amplify, filter, and transmit body sounds, and to calculate heart rate. The device is intended for use by healthcare professionals or lay users on pediatric and adult patients.
For lay users, the device output is not intended to be interpreted or used to take clinical action without consultation with a healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261694: CORE 300 Digital Stethoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261694
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026