Cleared Traditional

K243567 - Tyto Insights for Rhonchi Detection (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence.

K243567 · Tyto Care , Ltd. · Anesthesiology device
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Apr 2025
Decision
140d
Days
Class 2
Risk

K243567 is an FDA 510(k) clearance for the Tyto Insights for Rhonchi 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 April 7, 2025 after a review of 140 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 K243567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2024
Decision Date April 07, 2025
Days to Decision 140 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
1d slower than avg
Panel avg: 139d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. 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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Anesthesiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT06460246 Completed Interventional Industry-sponsored

Pulse Oximeter Accuracy During Stable Hypoxia Plateaus

12
Patients (actual)
1
Site
Other
Purpose
Open label
Masking
Condition studied Healthy
Study design Single group
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor Acurable Ltd. (industry)
Started 2024-06-25 → Primary completion 2024-06-27 → Completed 2024-07-31
Primary outcome
Performance of the pulse oximeters against corresponding arterial blood oxygen saturation.
Study completed - no results published. This trial concluded in 2024 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov