Cleared Special

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

Sep 2025
Decision
43d
Days
Class 2
Risk

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

Submitted by Airway Technologies D/B/A Airway Management (Farmers Branch, US). The FDA issued a Cleared decision on September 11, 2025, 43 days after receiving the submission on July 30, 2025.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.

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

Device Classification

Product Code LRK - Device, Anti-snoring
Device Class Class II - Special Controls
CFR Regulation 21 CFR 872.5570

Similar Devices - LRK Device, Anti-snoring

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
Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)
K233434 · Prismatik Dentalcraft, Inc. · Nov 2023
EndSnorZ Sleep Appliance
K211069 · Prismatik Dentalcraft, Inc. · Oct 2021
Silent Nite Sleep Appliance with the Glidewell Hinge
K210694 · Prismatik Dentalcraft, Inc. · Jun 2021