# K160016: Steth IO

- Pathway: 510(k) (Traditional)
- Applicant: Stratoscientific, Inc.
- Decided: Jul 15, 2016 after 192 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: 5 generations back to K771653 (1977). 7 ancestors in all.
4 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)
- K083903: 3M Littmann Electronic Stethoscope, Model 3200, 3M Company (2009) Summary page 5.

## Most influential descendants
- K222871: Stethophone v1 (2023), 3 descendants of its own
- 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
The StratoScientific Steth 10 Stethoscope and Phonocardiogram Model 1.0 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, and lungs with the use of selective frequency ranges. It has been tested for use on adults undergoing a physical assessment.

Source page: https://510kreport.com/device/K160016
Methodology: https://510kreport.com/methodology