Tyto Care , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252089Tyto Stethoscope (G3)March 12, 2026
K243567Tyto Insights for Rhonchi DetectionApril 7, 2025
K240555Tyto Insights for Crackles DetectionJuly 2, 2024
K232237Tyto Insights for Wheeze DetectionDecember 13, 2023
K221614TytoCare Lung Sounds AnalyzerFebruary 24, 2023
K190242Tyto ThermometerMarch 27, 2019
K181612Tyto Stethoscope (OTC)December 17, 2018
K160401Tyto StethoscopeOctober 19, 2016