Primary_care
Tyto Insights for Wheeze Detection
Tyto Care, Ltd.
FDA
FDA-cleared AI medical device
Over-the-counter AI-enabled decision-support software that automatically analyses the acoustic lung-sound signal recorded by the compatible Tyto Stethoscope in adults and children aged 2 years and older and identifies recordings where an abnormal lung sound suggestive of wheeze is suspected; it is not intended to detect other lung sounds, and a licensed healthcare professional's advice is required to understand the result.
FDA Submission Metadata
- Submission number
- K252844
- Decision date
- June 2026
- FDA panel
- Anesthesiology
- Product code
- PHZ
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA
Tyto Insights for Wheeze Detection (with PCCP) — 510(k) clearance (product code PHZ)
K252844
Class II