# K160401: Tyto Stethoscope

- Pathway: 510(k) (Traditional)
- Applicant: Tyto Care, Ltd.
- Decided: Oct 19, 2016 after 250 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 K952882 (1996). 19 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102893: PCP/PC Stethoscope, Rnk Products, Inc. (2011) Summary page 4.
- K083903: 3M Littmann Electronic Stethoscope, Model 3200, 3M Company (2009) Summary page 4.

## Most influential descendants
- K181612: Tyto Stethoscope (OTC) (2018), 19 descendants of its own
- K200776: Eko CORE (2020), 13 descendants of its own
- K231551: Stethophone (2023), 2 descendants of its own
- K210736: doctorgram Stethoscope DES-I (2021), 2 descendants of its own
- K240901: Stethophone (2024), 1 descendant of its own

## Indications for use
The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. The Tyto stethoscope is intended for use by professional users in a clinical environment or in conjunction with patients or lay users in a non-clinical environment.

Source page: https://510kreport.com/device/K160401
Methodology: https://510kreport.com/methodology