# K222871: Stethophone v1

- Pathway: 510(k) (Traditional)
- Applicant: Sparrow Acoustics, Inc.
- Decided: Mar 29, 2023 after 188 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: 6 generations back to K771653 (1977). 8 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160016: Steth IO, Stratoscientific, Inc. (2016) Summary page 5.
- K083903: 3M Littmann Electronic Stethoscope, Model 3200, 3M Company (2009) Summary page 5.

## Most influential descendants
- K231551: Stethophone (2023), 2 descendants of its own
- K240901: Stethophone (2024), 1 descendant of its own
- K252595: Stethophone Pro (2025), 0 descendants of its own

## Indications for use
Stethophone v1 is intended for medical diagnostic purposes only. It may be used for detection and amplification of sounds from the heart and lungs with the use of selective frequency ranges. It can be used on adults undergoing physical assessment.

Source page: https://510kreport.com/device/K222871
Methodology: https://510kreport.com/methodology