Clarissa Infant NCPAP Cannula
510(k) K032922
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032922 | Date22 Sep 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CBK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5895
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Clarissa Infant NCPAP Cannula is a nasal interface device designed for continuous positive airway pressure (CPAP) therapy. It provides a sealed connection within the nasal passages to deliver continuous airflow, maintaining airway patency in neonatal and infant patients under hospital or institutional monitoring. The device is classified as a ventilator accessory and is intended for use with continuous flow CPAP circuits or ventilators in continuous flow CPAP mode.
This single-use cannula features a swivel adapter compatible with 10mm breathing circuits, allowing secure connection to CPAP systems. It is intended for facility use only and is regulated under FDA 510(k) clearance (K032922) as a Class II device. The cannula is supplied sterile and must be discarded after a single use to ensure patient safety and infection control. No MRI safety information is specified.
Other devices from Airways Ltd., Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Clarissa Infant NCPAP Cannula used for?
The Clarissa Infant NCPAP Cannula is designed specifically for continuous positive airway pressure (CPAP) therapy in neonatal and infant patients. It provides a sealed connection within the nasal passages to deliver continuous airflow, helping maintain airway patency under hospital or institutional monitoring. This is particularly useful in settings where ventilator support or continuous flow CPAP circuits are available.
How is the Clarissa Infant NCPAP Cannula supplied, and is it sterile?
The Clarissa Infant NCPAP Cannula is supplied sterile and packaged for single-use only. This ensures patient safety and infection control, as it must be discarded immediately after use. The sterile packaging prevents contamination before and during use in a clinical setting.
Is the Clarissa Infant NCPAP Cannula reusable, or is it intended for single-use?
The Clarissa Infant NCPAP Cannula is explicitly intended for single-use only. Reuse is not recommended due to the risk of infection and compromised sterility. The device is designed to be discarded after one use to maintain patient safety and hygiene standards in hospital or institutional environments.
What type of connection does the Clarissa Infant NCPAP Cannula have, and what systems is it compatible with?
The cannula features a swivel adapter compatible with 10mm breathing circuits, allowing secure and stable connection to CPAP systems or ventilators operating in continuous flow CPAP mode. This ensures a reliable seal for delivering continuous airflow without dislodging during use.
Where should the Clarissa Infant NCPAP Cannula be stored, and what are the handling instructions?
The Clarissa Infant NCPAP Cannula should be stored in its original sterile packaging until ready for use. It must remain unopened and protected from contamination until immediate use. After opening, the cannula should be used promptly and discarded immediately following a single application to prevent cross-contamination and ensure compliance with infection control protocols.