# K193349: Vapocoolshot Mist

- Pathway: 510(k) (Traditional)
- Applicant: Vapocoolshot, Inc.
- Decided: Apr 14, 2020 after 133 days
- Product code: MLY (Vapocoolant Device)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K991514 (1999). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172028: Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray), Gebauer Company (2017) Summary page 4.
- K093951: Ouchless Model PN10114, Occam Design (2010) Summary page 4.

## Most influential descendants
- K201248: Syringe Holder accessory (2020), 0 descendants of its own

## Indications for use
The Vapocoolshot Mist is intended for topical application to skin, intact mucous membrane (oral cavity, nasal passageways, lips) and minor open wounds. The Vapocoolshot Mist is used to target and minimize cooling area for lessening pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical procedures (such as lancing boils, incision, drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts, and abrasions).

Source page: https://510kreport.com/device/K193349
Methodology: https://510kreport.com/methodology