Tyto Insights for Wheeze Detection (with PCCP)— 510(k) K252844

Name: FDA 510(k) clearance K252844
Creator: U.S. Food and Drug Administration
Published: 2026-06-02

Substantially Equivalent

Tyto Care , Ltd.

FDA 510(k) clearance K252844 for Tyto Insights for Wheeze Detection (with PCCP), Substantially Equivalent on 2026-06-02. Applicant: Tyto Care , Ltd.. Device class: 2.

Clearance details

Applicant: Tyto Care , Ltd.
Product code: Code PHZ
Device class: Class 2
Regulation: 21 CFR 868.1900
Advisory panel: Anesthesiology
Date received: 2025-09-08
Decision date: 2026-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

Download summary PDF View on FDA.gov ↗

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K232237 — Tyto Insights for Wheeze Detection2023-12-13
K221614 — TytoCare Lung Sounds Analyzer2023-02-24
K202062 — wheezo WheezeRate Detector2021-03-11

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K160401 — Tyto Stethoscope2016-10-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.