Cleared Traditional

K240555 - Tyto Insights for Crackles Detection (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K240555 is an FDA 510(k) clearance for the Tyto Insights for Crackles Detection. Classified as Abnormal Breath Sound Device (product code PHZ), Class II - Special Controls.

Submitted by Tyto Care , Ltd. (Netanya, IL). The FDA issued a Cleared decision on July 2, 2024 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1900 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tyto Care , Ltd. devices

Submission Details

510(k) Number K240555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 139d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

Device Classification

Product Code PHZ Abnormal Breath Sound Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1900
Definition The Device Is Intended To Measure Abnormal Breath Sound, Such As Wheeze, Rhonchi, And Whistling.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.