K240114 is an FDA 510(k) clearance for the UltraEzAir® (UEA1A). This device is classified as a Applicator (laryngo-tracheal), Topical Anesthesia (Class II - Special Controls, product code CCT).
Submitted by Dualams, Inc., Dba Airkor (Dallas, US). The FDA issued a Cleared decision on October 16, 2024, 274 days after receiving the submission on January 16, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5170.
| 510(k) Number | K240114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2024 |
| Decision Date | October 16, 2024 |
| Days to Decision | 274 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCT - Applicator (laryngo-tracheal), Topical Anesthesia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5170 |