FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 1 results

510(k) Data Aggregation

K Number

Device Name

Nylon flexTAP(R)

Manufacturer

Airway Technologies d/b/a Airway Management

Date Cleared

2025-09-11

(43 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K972061,K181482,K143244,K061732

Predicate For

N/A

Why did this record match?

Reference Devices :

K972061, K181482, K143244

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The Nylon flexTAP is intended to reduce or alleviate nighttime snoring and mild to moderate obstructive sleep apnea, OSA for adults, 18 years of age and older.

Device Description

The Nylon flexTAP is a custom-fit oral device intended to reduce or alleviate nighttime snoring and mild to moderate obstructive sleep apnea (OSA). The Nylon flexTAP device consists of 3 components:

Upper Tray that fits on the upper teeth
Lower Tray that fits on the lower teeth.
An Adjustment Mechanism attached to the lower tray that fits into an Adjustment Post on the upper tray.

AI/ML Overview

N/A

Ask a Question

Ask a specific question about this device

Page 1 of 1