Cleared Traditional

K243268 - TipTraQ (TTQ001) (FDA 510(k) Clearance)

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

K243268 · Pranaq Pte. , Ltd. · Anesthesiology device
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Feb 2025
Decision
111d
Days
Class 2
Risk

K243268 is an FDA 510(k) clearance for the TipTraQ (TTQ001). Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Pranaq Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on February 3, 2025 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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 Pranaq Pte. , Ltd. devices

Submission Details

510(k) Number K243268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2024
Decision Date February 03, 2025
Days to Decision 111 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
28d faster than avg
Panel avg: 139d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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.

Regulatory Consultant

Medignite Consulting, LLC
Amy Herder

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT06351878 Completed Observational Industry-sponsored

TipTraQ Home Sleep Test Validation Study, Duke

Validation of a Medical-grade Wearable Device with Interpretable Artificial Intelligence System for the Obstructive Sleep Apnea-hypopnea Syndrome (OSAHS) Screening

200
Patients (actual)
1
Site
Condition studied Obstructive Sleep Apnea
Eligibility All sexes · 20 Years+ · Healthy volunteers accepted
Sponsor PranaQ Pte. Ltd. (industry)
Started 2024-02-28 → Primary completion 2024-08-23
Primary outcome
Apnea Hypopnea Index(AHI)
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.
View full study on ClinicalTrials.gov