Tyto Care , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Tyto Insights for Wheeze Detection (with PCCP), Tyto Stethoscope (G3), Tyto Insights for Rhonchi Detection
10
Total
9
Cleared
1
Denied
FDA 510(k) Regulatory Record - Tyto Care , Ltd. Anesthesiology ✕
5 devices
Cleared
Jun 02, 2026
Tyto Insights for Wheeze Detection (with PCCP)
Anesthesiology
267d
Cleared
CT
Apr 07, 2025
Tyto Insights for Rhonchi Detection
Anesthesiology
140d
Cleared
Jul 02, 2024
Tyto Insights for Crackles Detection
Anesthesiology
125d
Cleared
Dec 13, 2023
Tyto Insights for Wheeze Detection
Anesthesiology
138d
Cleared
Feb 24, 2023
TytoCare Lung Sounds Analyzer
Anesthesiology
266d