Tyto Care , Ltd. - FDA 510(k) Cleared Devices

Tyto Care, Ltd. develops remote clinical examination devices and AI-powered diagnostic solutions for virtual care delivery. The company enables clinicians to conduct comprehensive physical exams from patient homes and community settings, with a manufacturing facility in Netanya, IL.

Tyto Care has received 8 FDA 510(k) clearances from 9 total submissions since 2016. The company specializes in respiratory and cardiovascular diagnostic devices, including AI-powered lung sound analysis and digital stethoscope technology. The latest clearance was granted in 2026, confirming active regulatory engagement.

Recent FDA 510(k) cleared devices span Anesthesiology and Cardiovascular categories, featuring advanced algorithms for detecting respiratory abnormalities such as wheeze, crackles, and rhonchi, alongside clinical-grade thermometry and heart sound analysis. The company's Tyto Insights platform represents a shift toward AI-guided clinical intelligence in home-based diagnostics.

Explore the complete list of cleared device names, product codes, and clearance dates in the 510(k) database.

1 device has linked clinical trial registered on ClinicalTrials.gov. 2 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.