Cleared Traditional

TytoCare Lung Sounds Analyzer

K221614 · Tyto Care , Ltd. · Anesthesiology

Feb 2023

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K221614 is an FDA 510(k) clearance for the TytoCare Lung Sounds Analyzer, 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 February 24, 2023, 266 days after receiving the submission on June 3, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1900.

Submission Details

510(k) Number	K221614 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 2022
Decision Date	February 24, 2023
Days to Decision	266 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.