Cleared Special

K252374 - Nylon flexTAP(R) (FDA 510(k) Clearance)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K252374 · Airway Technologies D/B/A Airway Management · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
43d
Days
Class 2
Risk

K252374 is an FDA 510(k) clearance for the Nylon flexTAP(R). Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Airway Technologies D/B/A Airway Management (Farmers Branch, US). The FDA issued a Cleared decision on September 11, 2025 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Airway Technologies D/B/A Airway Management devices

Submission Details

510(k) Number K252374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2025
Decision Date September 11, 2025
Days to Decision 43 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 127d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LRK Device, Anti-snoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
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 Dental devices follow this clearance model.

Regulatory Consultant

ProMedic, LLC
Paul Dryden

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.

Regulatory Peers - LRK Device, Anti-snoring

All 209
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K252374.
ShaeferH
K252942 · Shaeferh, LLC · Apr 2026
Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
K253845 · Ram.Shaw Pte. , Ltd. · Mar 2026
Myosa (S1H, S1, S2, S3, S1M, S2M)
K252531 · Myofunctional Research Co. · Mar 2026
Park Dental Nylon MAD
K252976 · Park Dental Research Corp. · Dec 2025
QuietLab Pro
K253868 · QuietLab, LLC · Dec 2025
Hushd Avera
K252161 · Good Sleep CO Pte , Ltd. · Nov 2025