510(k) K252844
K252844 is an FDA 510(k) premarket notification submitted by Tyto Care , Ltd. for the device "Tyto Insights for Wheeze Detection (with PCCP)". The FDA issued a decision of Substantially Equivalent on June 2, 2026. The device falls under product code PHZ (Abnormal Breath Sound Device), a Class II device regulated under 21 CFR 868.1900. Tyto Care , Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 2026
- Date Received
- September 8, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Abnormal Breath Sound Device
- Device Class
- Class II
- Regulation Number
- 868.1900
- Review Panel
- AN
- Submission Type
The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.