# K201248: Syringe Holder accessory

- Pathway: 510(k) (Traditional)
- Applicant: Vapocoolshot, Inc.
- Decided: Aug 12, 2020 after 93 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: 6 generations back to K991514 (1999). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193349: Vapocoolshot Mist, Vapocoolshot, Inc. (2020) Summary page 4.
- K093951: Ouchless Model PN10114, Occam Design (2010) Summary page 4.

## 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) The Syringe Holder accessory is intended to be attached to the Nozzle of the Vapocoolshot Mist and allows for the attachment of a user supplied syringe 1cc (4.5mm) to 3 cc (10.8mm) in diameter to facilitate the injection procedure following Vapocoolshot Mist application.

Source page: https://510kreport.com/device/K201248
Methodology: https://510kreport.com/methodology