Chrysalis Intelligence · Sponsors · Tyto Care , Ltd.

Tyto Care , Ltd.

Netanya, IL · 7 510(k) clearances

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Total clearances
7
2023-02-24 → 2026-06-02
Last 12 months
3
Product codes
3
Most recent
2026-06-02
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
PHZ Abnormal Breath Sound Device Class II Anesthesiology 5 2026-06-02
SHL Ear, Nose, And Throat Image Analyzer Class II Ear, Nose, Throat 1 2026-03-17
DQD Stethoscope, Electronic Class II Cardiovascular 1 2026-03-12
Filings

All 510(k) clearances (7)

Date K-number Device Code Class Specialty
2026-06-02 K252844 Tyto Insights for Wheeze Detection (with PCCP) PHZ Class II Anesthesiology
2026-03-17 DEN250014 Tyto Insights for Eardrum Bulging Detection SHL Class II Ear, Nose, Throat
2026-03-12 K252089 Tyto Stethoscope (G3) DQD Class II Cardiovascular
2025-04-07 K243567 Tyto Insights for Rhonchi Detection PHZ Class II Anesthesiology
2024-07-02 K240555 Tyto Insights for Crackles Detection PHZ Class II Anesthesiology
2023-12-13 K232237 Tyto Insights for Wheeze Detection PHZ Class II Anesthesiology
2023-02-24 K221614 TytoCare Lung Sounds Analyzer PHZ Class II Anesthesiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence