# K220470: Smart Wireless Stethoscope

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Hulu Devices Co., Ltd.
- Decided: May 23, 2022 after 94 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: 9 generations back to K952882 (1996). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200776: Eko CORE, Eko Devices, Inc. (2020) Summary page 5.

## Most influential descendants
- K261494: Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730) (2026), 0 descendants of its own

## Indications for use
The Smart Wireless Stethoscope enables amplification, filtering, and transmission of auscultation sounds from the heart, lungs, bowel, arteries, and veins. A medical professional at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. The device is intended for use on pediatric and adult patients. The device 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.

Source page: https://510kreport.com/device/K220470
Methodology: https://510kreport.com/methodology