Cleared Traditional

Tyto Insights for Wheeze Detection (with PCCP) (K252844) - FDA 510(k) Clearance

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

K252844 · Tyto Care , Ltd. · Anesthesiology device
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Jun 2026
Decision
267d
Days
Class 2
Risk

K252844 is an FDA 510(k) clearance for the Tyto Insights for Wheeze Detection (with PCCP). 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 June 2, 2026 after a review of 267 days - an extended review cycle.

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 K252844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2025
Decision Date June 02, 2026
Days to Decision 267 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 139d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - PHZ Abnormal Breath Sound Device

Devices cleared under the same product code (PHZ) and FDA review panel - the closest regulatory comparables to K252844.
Tyto Insights for Rhonchi Detection
K243567 · Tyto Care , Ltd. · Apr 2025
Tyto Insights for Crackles Detection
K240555 · Tyto Care , Ltd. · Jul 2024
Tyto Insights for Wheeze Detection
K232237 · Tyto Care , Ltd. · Dec 2023
TytoCare Lung Sounds Analyzer
K221614 · Tyto Care , Ltd. · Feb 2023
wheezo WheezeRate Detector
K202062 · Respiri Limited · Mar 2021