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Nylon FlexTap

by Airway Technologies D/B/A Airway Management

510(k) K252374

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK252374 Date11 Sep 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Nylon flexTAP(R)
510(k) Number
FDA Product Code
LRK
Device Class
Class II
Regulation
21 CFR Part 872.5570
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Nylon FlexTap is an intraoral device classified as an anti‑snoring appliance. It is intended to be placed in the mouth to reduce snoring by supporting the airway during sleep.

The device is marketed by Airway Technologies d/b/a Airway Management and received FDA 510(k) clearance (K252374) on 2025‑09‑11 under 21 CFR 872.5570 as a Class II device. It is supplied as a single‑use product, with no specific sterility or MRI safety information provided in the available data.