Cleared Traditional

Tyto Insights for Rhonchi Detection

K243567 · Tyto Care , Ltd. · Anesthesiology
Apr 2025
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K243567 is an FDA 510(k) clearance for the Tyto Insights for Rhonchi Detection, a Abnormal Breath Sound Device (Class II — Special Controls, product code PHZ), submitted by Tyto Care , Ltd. (Netanya, IL). The FDA issued a Cleared decision on April 7, 2025, 140 days after receiving the submission on November 18, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1900.

Submission Details

510(k) Number K243567 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2024
Decision Date April 07, 2025
Days to Decision 140 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code PHZ — Abnormal Breath Sound Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1900
Definition The Device Is Intended To Measure Abnormal Breath Sound, Such As Wheeze, Rhonchi, And Whistling.