# K240114: UltraEzAir® (UEA1A)

- Pathway: 510(k) (Traditional)
- Applicant: Dualams, Inc., Dba Airkor
- Decided: Oct 16, 2024 after 274 days
- Product code: CCT (Applicator (Laryngo-Tracheal), Topical Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002255 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153470: MADgic Laryngo-Tracheal Mucosal Atomization Device, Teleflex Medical (2016) Summary page 5.

## Indications for use
The UltraEzAir® is a topical anesthesia applicator used to apply topical anesthetic to a patient's oropharynx and upper airway region through the working channel of a flexible nasal laryngoscope using air flow. The device is designed for and intended to be used by physicians trained and experienced in flexible endoscopic techniques for elective outpatient procedures. The safety and effectiveness of this device for use in the performance of topical anesthesia of the lower airways (below the level of the trachea) have not been established.

Source page: https://510kreport.com/device/K240114
Methodology: https://510kreport.com/methodology