# K153470: MADgic Laryngo-Tracheal Mucosal Atomization Device

- Pathway: 510(k) (Traditional)
- Applicant: Teleflex Medical
- Decided: Aug 19, 2016 after 261 days
- Product code: CCT (Applicator (Laryngo-Tracheal), Topical Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5170
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002255 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002255: Laryngo-Tracheal Mucosal Atomization Device (Madgic), Wolfe Tory Medical, Inc. (2000) Summary page 4.

## Most influential descendants
- K240114: UltraEzAir® (UEA1A) (2024), 0 descendants of its own

## Recalls of this device
- Jul 5, 2017 · Class II · Z-3212-2017: Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
- Oct 27, 2016 · Class II · Z-0383-2017: Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
- Oct 27, 2016 · Class II · Z-0384-2017: Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

## Indications for use
The MADgic Laryngo-Tracheal Mucosal Atomization Device is intended for the application of topical anesthetics to the oropharynx and upper airway region.

Source page: https://510kreport.com/device/K153470
Methodology: https://510kreport.com/methodology