# K031697: DR. Scholl's Freeze Away Wart Remover, Model 40226

- Pathway: 510(k) (Traditional)
- Applicant: Schering-Plough Healthcare Products, Inc.
- Decided: Aug 29, 2003 after 88 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K911420 (1991). 5 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011708: Modification to Wartner Wart Removal System, Wartner Medical Products (2002)
- K023487: Histofreezer Wart Removal System or Other Proprietary Name, OraSure Technologies, Inc. (2003) Summary page 1.
- K924114: Histofreezer, Solarcare Technologies Corp,Inc. (1993) Summary page 1.

## Most influential descendants
- K140314: Wartie Wart Remover (2014), 8 descendants of its own
- K172373: Compound W Nitro-Freeze (2017), 3 descendants of its own
- K242932: Skin Clinic Nitro Clear Wart Remover (2025), 1 descendant of its own
- K052259: DR. Scholl's Dual Action Freeze Away Wart Remover, Model 40406 (2005), 1 descendant of its own
- K253000: CryoFreeze Wart and Skin Tag Remover (2025), 0 descendants of its own

## Indications for use
For the over-the-counter removal of common warts and plantar warts on the bottom of the foot.

Source page: https://510kreport.com/device/K031697
Methodology: https://510kreport.com/methodology