# K212906: HeartBuds Electronic Stethoscope

- Pathway: 510(k) (Traditional)
- Applicant: Heartbuds, LLC
- Decided: Mar 14, 2023 after 547 days
- Product code: DQD (Stethoscope, Electronic)
- Device class: 2
- Regulation: 21 CFR 870.1875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K952882 (1996). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181612: Tyto Stethoscope (OTC), Tyto Care, Ltd. (2018) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K212906
Methodology: https://510kreport.com/methodology