Cleared Traditional

Tyto Insights for Crackles Detection

K240555 · Tyto Care , Ltd. · Anesthesiology
Jul 2024
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K240555 is an FDA 510(k) clearance for the Tyto Insights for Crackles Detection, a Abnormal Breath Sound Device (Class II — Special Controls, product code PHZ), submitted by Tyto Care , Ltd. (Natanya, IL). The FDA issued a Cleared decision on July 2, 2024, 125 days after receiving the submission on February 28, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1900.

Submission Details

510(k) Number K240555 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2024
Decision Date July 02, 2024
Days to Decision 125 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.