510(k) · Cleared
ClearedeClinic Stethopod
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Homediagnostic, LLC · DQD Stethoscope, Electronic
Cleared on Oct 20, 2022 as substantially equivalent to K200776 (Eko Devices, Inc., 2020) after a 281-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Oct 20, 2022
- Review
- 281 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 deviceK220099 eClinic StethopodHomediagnostic, LLC · 2022
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 deviceK220099 eClinic StethopodHomediagnostic, LLC · 2022
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) | K220099 | eClinic Stethopod | Homediagnostic, LLC | 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 |
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 4…21 CFR870.1875 Product Code: DQD 5.3 Legally Marketed Predicate Device The predicate device for eClinic Stethopod is legally marketed Eko Core (K200776). 5.4 Device Description 5.4.1 Device Identification eClinic Stethopod is an electronic stethoscope that is design… | 2020 |
| † | K151319 | Eko Electronic Stethoscope System | 2015 |
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 26 years and passes through 6 companies; a new generation was cleared every 2.5 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. 2022, 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?
eClimic Stethopod 1s an Electronic Stethoscope. It converts patient auscultation sound (heart, ngs, bowel, arteries, and veins) into audio signal and transmits it to clinicians by clmically defined virtual appointment methods.
It 1s intended to be used by professional users in a clinical environment or by lay users in a nonclinical or climical environment fo assist remote healthcare professionals’ physical assessment. The device is not intended for self-diagnosis. eClmic Stethopod 1s intended for patients or customers who are 2 years and older. It is for both prescription use and over the counter use.
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/K220099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220099: eClinic Stethopod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220099
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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