# K093951: Ouchless Model PN10114

- Pathway: 510(k) (Traditional)
- Applicant: Occam Design
- Decided: Jun 15, 2010 after 174 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
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K193349: Vapocoolshot Mist (2020), 1 descendant of its own
- K201248: Syringe Holder accessory (2020), 0 descendants of its own

## Indications for use
Use like ice for the temporary relief of minor localized pain.

Source page: https://510kreport.com/device/K093951
Methodology: https://510kreport.com/methodology