FDA AI Clearance Tracker/K252844
Anesthesiology · 510(k)
Tyto Insights for Wheeze Detection (with PCCP)
Tyto Care , Ltd.
- Device
- Tyto Insights for Wheeze Detection (with PCCP)
- Company
- Tyto Care , Ltd.
- Submission number
- K252844
- Pathway
- 510(k)
- Decision date
- Jun 2, 2026
- Specialty (lead panel)
- Anesthesiology
- Primary product code
- PHZ
Source: U.S. FDA AI-Enabled Medical Devices list. The FDA says the list is not comprehensive. Confirm details on the FDA's own record.