Comfort Twin Nasal Mask

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

510(k) Number

K091843 ↗

FDA Product Code

BZD

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Performax Se Total Face Mask

  Class II

  FDA 510(k) K072588 Active Cleared 18 Dec 2007

• Performax Total Face Mask

  Class II

  FDA 510(k) K072592 Active Cleared 19 Dec 2007

• Remstar Auto a-Flex Open recall

  Class II

  FDA 510(k) K091319 Active Cleared 3 Aug 2009

• Bipap Synchrony 2 Ventilatory Support System

  Class II

  FDA 510(k) K071509 Active Cleared 8 Aug 2007

• Gas Transfill

  Class II

  FDA 510(k) K091191 Active Cleared 23 Oct 2009

• Remstar Aflex Cpap System

  Class II

  FDA 510(k) K063830 Active Cleared 9 Mar 2007

See all devices from Respironics Inc., Sleep & Home Respiratory Group →

• What types of patients is the Comfort Twin Nasal Mask designed for, and where can it be used?

  The Comfort Twin Nasal Mask is specifically designed for adult patients only and is intended for use in hospital, clinic, or home settings. It is a ventilator accessory meant to deliver continuous positive airway pressure (CPAP) or bi-level therapy via non-continuous ventilators (respirators).

• Is the Comfort Twin Nasal Mask reusable, and if not, how should it be handled after use?

  No, the Comfort Twin Nasal Mask is not reusable—it is supplied as a single-use accessory. After use, it should be disposed of according to standard medical device protocols for single-use respiratory accessories to ensure patient safety and infection control.

• Which ventilator models is this mask compatible with, and how do I verify compatibility?

  The Comfort Twin Nasal Mask is compatible with multiple ventilator models, as listed under the registration numbers provided (e.g., 3030970580, 3010440667, etc.). To verify compatibility, check if your ventilator’s registration number appears in the list under 868.5905 or consult the manufacturer’s documentation for your specific device.

• Can this mask be used with patients who require MRI scans, and how should it be stored?

  The Comfort Twin Nasal Mask is not MRI-compatible, so it should not be used with patients undergoing MRI procedures. For storage, follow standard medical device protocols for single-use respiratory accessories, ensuring it remains in a clean, dry environment and protected from contamination until use.

• What regulatory pathway was followed for FDA clearance of this device, and what class does it fall under?

  The Comfort Twin Nasal Mask received FDA 510(k) clearance under the traditional pathway, classified as Class II. The clearance number is K091843, and it was determined to be substantially equivalent to a predicate device. The advisory committee involved was Anesthesiology (AN).