AirPilotMask Model TMS-900

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

510(k) Number

K992192 ↗

FDA Product Code

BZD

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

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

  Class II

  FDA 510(k) K051583 Active Cleared 4 Nov 2005

• 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 AirPilotMask Model TMS-900 primarily used for in clinical settings?

  The AirPilotMask Model TMS-900 is designed to deliver continuous positive airway pressure (CPAP) therapy, which is specifically intended for treating obstructive sleep apnea in adults. It functions as a ventilator for non-continuous use, helping maintain open airways during sleep to improve breathing and reduce symptoms of sleep apnea.

• Is the AirPilotMask Model TMS-900 intended for single-use or reusable applications?

  The AirPilotMask Model TMS-900 is intended for single-patient reuse, meaning it is meant to be used by one individual at a time. However, it is non-sterile and requires cleaning between uses to ensure proper hygiene and functionality.

• How is the AirPilotMask Model TMS-900 regulated by the FDA, and what does this mean for its use?

  The AirPilotMask Model TMS-900 holds an FDA 510(k) clearance (K992192) and is classified as substantially equivalent to a predicate device under 21 CFR 868.5905. This means it has been reviewed and determined to be as safe and effective as a previously approved device, allowing it to be legally marketed and used in clinical settings like sleep laboratories or home environments.

• What types of environments is the AirPilotMask Model TMS-900 suitable for, and how should it be maintained?

  The AirPilotMask Model TMS-900 is supplied for use in clinical settings such as sleep laboratories or home environments. To ensure proper function and hygiene, it must be cleaned and maintained according to the manufacturer’s guidelines between uses, as it is non-sterile and intended for single-patient reuse.

• Are there different sizes or models of the AirPilotMask available, and how would I identify the correct fit for a patient?

  The provided data lists multiple FEI numbers (e.g., 3030970580, 3010440667), which may correspond to different sizes or variations of the AirPilotMask Model TMS-900. While the exact sizing details are not specified, these identifiers likely represent different product lots or configurations. For precise sizing and fit, refer to the manufacturer’s instructions or consult a healthcare professional to ensure the correct mask is selected for the patient’s needs.