510(k) · Cleared
ClearedHeartBuds Electronic Stethoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartbuds, LLC · DQD Stethoscope, Electronic
Cleared on Mar 14, 2023 as substantially equivalent to K181612 (Tyto Care, Ltd., 2018) after a 547-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Mar 14, 2023
- Review
- 547 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K952882 (1996). 22 ancestors in all, the oldest K771653 (1977). No later device cites it as a predicate yet.
- 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 deviceK212906 HeartBuds Electronic StethoscopeHeartbuds, LLC · 2023
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) | K212906 | HeartBuds Electronic Stethoscope | Heartbuds, LLC | 2023 | — |
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 |
| 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 |
|---|---|---|---|
| * | K181612 | Tyto Stethoscope (OTC)Summary page 4…21 CFR 870.1875 (DQD) Classification Panel: Cardiovascular diagnostics A. Legally Marketed Predicate Devices The predicate device is the Tyto Stethoscope (K181612). B. Device Description: HeartBuds is an electronic stethoscope intended to auscultate heart and lung sounds. HeartBuds Stethosc… | 2018 |
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 27 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- None of the 22 ancestors has a recall.
- 5 other devices also cite its predicate K181612.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 HeartBuds Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a
clinician at one location via the HeartBuds mobile application can listen to the auscultation sounds of a patient at a
different location. The HeartBuds Stethoscope is intended to be used by professional users in a clinical environment or by
non medical professional adult users in a non clinical environment. The device is for medical diagnostics purposes only.
The device is not intended for self-diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212906 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212906: HeartBuds Electronic Stethoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212906
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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