Identifiers
- 510(k) Number
- K053352 FDA 510(k)
- FDA Product Code
- BZD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5905 FDA 510(k)
- Regulation Number
- 868.5905 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ComfortLite Nasal Mask is a nasal mask designed for respiratory support, delivering oxygen or ventilatory assistance to patients. It features a lightweight, cushioned design to enhance patient comfort and improve seal integrity during use, making it suitable for continuous or non-continuous ventilatory applications in clinical settings.
This device is intended for single-use and is supplied sterile, adhering to FDA 510(k) clearance under the Anesthesiology advisory committee. It is classified as a Class II medical device and is regulated under the Ventilator, Non-Continuous (Respirator) category. Multiple cushion options (e.g., Pillows, Simple Cushion, Direct Seal Cushion) are available, and replacement parts may be provided for maintenance. Storage and handling should follow sterile protocols as per manufacturer guidelines.
Frequently asked questions
What types of cushion options are available for the ComfortLite Nasal Mask, and how do they differ in use?
The ComfortLite Nasal Mask offers multiple cushion options, including Pillows, Simple Cushion, and Direct Seal Cushion. These variations are designed to enhance patient comfort and improve seal integrity during respiratory support or ventilatory assistance. The choice of cushion may depend on patient-specific needs, such as facial anatomy or ease of application, to ensure a secure fit while minimizing pressure points.
Is the ComfortLite Nasal Mask intended for single-use or reusable applications, and what does this mean for clinical workflows?
The ComfortLite Nasal Mask is explicitly designed for single-use only, meaning it is intended to be used once per patient and then discarded. This design choice aligns with sterile protocols to reduce infection risks and ensures patient safety. Clinically, this means each mask must be opened from a sterile package for a single patient, and replacement masks must be sourced for subsequent use, streamlining workflows but requiring careful inventory management.
How should the ComfortLite Nasal Mask be stored to maintain its sterility and functionality?
Since the ComfortLite Nasal Mask is supplied sterile, storage must follow manufacturer guidelines to preserve sterility and integrity. It should be kept in its original, sealed packaging until ready for use, away from direct sunlight, extreme temperatures, or contaminants. Proper storage ensures the mask remains free of microbial growth and maintains its cushioning and sealing properties for optimal performance.
Are replacement parts available for the ComfortLite Nasal Mask, and if so, what components can be replaced?
Yes, replacement parts may be provided for maintenance of the ComfortLite Nasal Mask. While the exact components aren’t detailed in the data, this typically includes consumable elements like cushions or connectors that may wear out or require replacement during routine use. Replacements help extend the usability of the mask system while maintaining patient comfort and seal integrity.
What regulatory pathway was followed for FDA clearance of the ComfortLite Nasal Mask, and what does this mean for clinicians?
The ComfortLite Nasal Mask received FDA clearance through a 510(k) submission, classified as substantially equivalent under the Anesthesiology advisory committee. This means the device was evaluated against a predicate (a previously cleared device) to demonstrate safety and effectiveness for its intended use—delivering respiratory support or ventilatory assistance. Clinically, this clearance indicates the mask meets FDA standards for use in non-continuous ventilatory applications, but it does not imply approval for specific clinical scenarios beyond its labeled purpose.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ComfortLite 2 Nasal Mask Instructions | Manualzz, Respironics ComfortLite 2 Nasal Mask User Guide - Manualzz, Respironics ComfortLite 2 Instructions For Use Manual, ComfortLite™ Nasal Mask With Simple Cushion - Respironics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K053352 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA 510(k) K053352 24 fields · synced Sep 19, 2026