# K070596: Topical Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Sharn, Inc.
- Decided: Jun 21, 2007 after 111 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 K852544 (1985). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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 1.
- K852544: Monoject Sterile 3CC Syringes W/ & WO/ Needles, Sherwood Medical Co. (1985) Summary page 1.

## Most influential descendants
- K093584: EZ-Mister (2011), 0 descendants of its own

## Recalls of this device
- Mar 5, 2009 · Not classified · Z-0266-2010: Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.
- Mar 5, 2009 · Not classified · Z-0267-2010: Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.
- Mar 5, 2009 · Not classified · Z-0265-2010: Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.

## Indications for use
Intended for atomizing topical anesthetics to the oropharynx and upper airway regions

Source page: https://510kreport.com/device/K070596
Methodology: https://510kreport.com/methodology