510(k) · Anesthesiology

Tyto Insights for Crackles Detection

by Tyto Care Ltd.

Tyto Insights for Crackles Detection is an AI-enabled medical device from Tyto Care Ltd. that the U.S. FDA cleared through 510(k) K240555 on July 2, 2024. Its lead review panel is Anesthesiology and its primary product code is PHZ (Abnormal Breath Sound Device).

See also FDA-cleared AI anesthesiology devices in 2024, all FDA AI clearances in 2024, top anesthesiology AI devices.

Key facts

Submission numberK240555
Pathway510(k)
Date of final decision
Company (FDA list)Tyto Care Ltd.
Lead review panelAnesthesiology
Primary product codePHZ — Abnormal Breath Sound Device
Applicant (openFDA)Tyto Care , Ltd.
Applicant locationNetanya, IL
Device classClass 2
Regulation number21 CFR 868.1900
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Tyto Insights for Crackles Detection went through this pathway (K240555).

openFDA lists it as a Class 2 device under 21 CFR 868.1900. Class II devices are moderate risk and are subject to general and special controls.

Product code PHZ covers 4 devices on the FDA AI list. By decision date, this device is #2 of 4 under that code. Tyto Care Ltd. has 7 AI-enabled devices on the list, and the Anesthesiology panel accounts for 30 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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