Company profile

Tyto Care , Ltd.

Tyto Care , Ltd. has 7 AI-enabled medical devices on the FDA list. The first decision was on October 19, 2016 and the most recent on June 2, 2026 (Tyto Insights for Wheeze Detection (with PCCP)). Its most common review panel is Anesthesiology (4 devices).

7AI devices

2016First decision

2026Latest decision

3Specialties

Per year

20162023202420252026

Tyto Care , Ltd. AI devices per year: 2016 1, 2023 1, 2024 1, 2025 1, 2026 3

By specialty

Anesthesiology4
Cardiovascular2
Ear Nose & Throat1

Timeline

June 2, 2026 · 510(k) K252844Tyto Insights for Wheeze Detection (with PCCP) · Anesthesiology · PHZ
March 17, 2026 · De Novo DEN250014Tyto Insights for Eardrum Bulging Detection · Ear Nose & Throat · SHL
March 12, 2026 · 510(k) K252089Tyto Stethoscope (G3) · Cardiovascular · DQD
April 7, 2025 · 510(k) K243567Tyto Insights for Rhonchi Detection · Anesthesiology · PHZ
July 2, 2024 · 510(k) K240555Tyto Insights for Crackles Detection · Anesthesiology · PHZ
December 13, 2023 · 510(k) K232237Tyto Insights for Wheeze Detection · Anesthesiology · PHZ
October 19, 2016 · 510(k) K160401Tyto Stethoscope · Cardiovascular · DQD