Tiara Snapp X Soft Nasal Accessory for Positive Pressure, Models Tms-3020, Tms-3030, Tms- 3040, Tms-3050

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

510(k) Number

K051583 ↗

FDA Product Code

BZD

Models / Variants

Tms-3020

Tms-3030

Tms- 3040

Tms-3050

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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

  Class II

  FDA 510(k) K043382 Active Cleared 19 Jan 2005

• Tms Snapp Soft Nasal Accessory for Positive Pressure, Models Tms-3020, Tms-3030 & Tms-3040

  Class II

  FDA 510(k) K034053 Active Cleared 24 Jun 2004

• Advantage Nasal Mask, Small, Advantage Nasal Mask. Regular, Models Tms-2520, Tms 2530

  Class II

  FDA 510(k) K012207 Active Cleared 23 Jul 2001

• AirPilotMask Model TMS-900

  Class II

  FDA 510(k) K992192 Active Cleared 12 May 2000

• Tiara Medical Systems Advantage II Nasal Mask, Models Tms-2520 and Tms-2530

  Class II

  FDA 510(k) K031935 Active Cleared 3 Mar 2004

• Tms Comfort Series Nasal Cpap Mask

  Class II

  FDA 510(k) K964092 Active Cleared 31 Jul 1997

• What is the TIARA SNAPP X Soft Nasal Accessory used for?

  It is intended to be used with continuous positive airway pressure (CPAP) devices operating at or above 3 cmH2O for the treatment of obstructive sleep apnea, as a soft nasal accessory designed for use with positive pressure devices.

• How is the TIARA SNAPP X Soft Nasal Accessory supplied and what models are available?

  The device is supplied as models TMS-3020, TMS-3030, TMS-3040, and TMS-3050, which are soft nasal accessories designed for use with positive pressure devices such as CPAP systems.

• Is the TIARA SNAPP X Soft Nasal Accessory reusable or single-use?

  The device data does not specify whether the TIARA SNAPP X Soft Nasal Accessory is reusable or single-use; therefore, no determination can be made about its reusability based on the provided information.

• What regulatory pathway was used for the TIARA SNAPP X Soft Nasal Accessory?

  The device received FDA 510(k) clearance under K051583 and is classified as a Class II medical device, indicating it was cleared through the 510(k) premarket notification process as substantially equivalent to a predicate device.