ComfortGel Full Face Mask

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

510(k) Number

K073600 ↗

FDA Product Code

BZD

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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

• What clinical settings is the ComfortGel Full Face Mask intended for, and how does its design support patient comfort during use?

  The ComfortGel Full Face Mask is designed for single-use in clinical settings such as operating rooms and intensive care units, where anesthesia and non-continuous respiratory support are administered. Its gel-based cushion system ensures a secure seal around the patient’s face, reducing pressure points and improving comfort during mechanical ventilation. This design minimizes skin irritation and enhances patient tolerance during prolonged procedures.

• Is the ComfortGel Full Face Mask reusable, or is it meant for one-time use? How should it be stored to maintain sterility?

  The ComfortGel Full Face Mask is explicitly intended for single-use only in clinical environments. To preserve sterility, it must be stored in a clean, dry environment away from direct sunlight or moisture. Opening the packaging or exposing it to contaminants before use could compromise its sterile condition, so it should only be handled in sterile fields.

• What sizes are available for the ComfortGel Full Face Mask, and how do I determine the correct fit for a patient?

  The ComfortGel Full Face Mask is available in standard sizes, though the exact sizing options are not detailed in the provided data. Fit is critical for seal integrity and patient comfort, so clinicians should follow manufacturer guidelines (likely included in packaging or user manuals) to select the appropriate size based on the patient’s facial dimensions. A proper fit ensures effective airflow delivery and minimizes leakage.

• What regulatory pathway was followed for FDA clearance of the ComfortGel Full Face Mask, and which medical specialty does it align with?

  The ComfortGel Full Face Mask received FDA 510(k) clearance (K073600) under a *Traditional* review pathway, determined to be *substantially equivalent* to a predicate device. It is classified under the Anesthesiology medical specialty, reflecting its primary use in procedures requiring ventilator support during anesthesia administration. The clearance aligns with ventilator device standards for non-continuous respiratory support.