IntelAir Nasal Airway Support System
510(k) K142467
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142467 | Date24 Nov 2014 | 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- Withdrawn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
- CCK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1400
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The IntelAir Nasal Airway Support System is a nasopharyngeal airway device designed to maintain airway patency in patients requiring respiratory support. It combines an airway tube with accessory tubes for supplemental oxygen delivery and carbon dioxide sampling, enabling capnography monitoring. The system is intended for use in procedural sedation, anesthesia, and critical care settings where secure airway management is essential. Its design helps prevent cannula migration and ensures stable airway securement during clinical procedures.
This device is supplied as a non-sterile, single-use system and includes an airway tube, oxygen delivery tube, CO₂ sampling tube, and an optional magnetic securement system (comprising a catheter assembly, retrieval probe, and stylet). It is regulated under 21 CFR 868.1400 as a Class II medical device with FDA 510(k) clearance (K142467). The system is intended for use in procedural sedation and anesthesia, adhering to AN (Anesthesiology) Advisory Committee guidelines. Storage and handling follow standard single-use medical device protocols.