Skip to content

Tms Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840

by Tiara Medical Systems, Inc.

510(k) K043382

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 · Traditional NumberK043382 Date19 Jan 2005ClearedStatusActive

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  • Withdrawn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)

510(k) Number
FDA Product Code
BZD
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 868.5905
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

The Tms Full Advantage Full Face Mask is a non-continuous ventilator accessory designed to cover the mouth and nose of a patient. It provides a seal to facilitate the delivery of positive airway pressure for the treatment of adult obstructive sleep apnea.

This device is intended for use with positive airway pressure devices such as CPAP. It is authorized under FDA 510(k) number K043382 and is available in models Tms-2820, Tms-2830, and Tms-2840.

Other devices from Tiara Medical Systems, Inc.

Questions

AI-generated answers, 21 Sep 2026

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

  • What is the intended use of the TMS Full Advantage Full Face Mask?

    This device is designed to cover both the mouth and nose of a patient to provide a seal for the delivery of positive airway pressure. It is specifically indicated for the treatment of adult obstructive sleep apnea.

  • Which positive airway pressure devices is this mask compatible with?

    The mask is intended for use with positive airway pressure devices, such as CPAP (Continuous Positive Airway Pressure) machines, to facilitate the delivery of therapy.

  • What model numbers are available for this mask?

    The TMS Full Advantage Full Face Mask is available in three distinct model numbers: TMS-2820, TMS-2830, and TMS-2840.

  • What is the regulatory status of this device?

    This device is authorized under FDA 510(k) number K043382, which confirms its status as a non-continuous ventilator accessory for the specified clinical indications.