# K140314: Wartie Wart Remover

- Pathway: 510(k) (Traditional)
- Applicant: Yonmedical BV
- Decided: Jun 12, 2014 after 122 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: 4 generations back to K911420 (1991). 9 ancestors in all.
8 later devices descend from it; 6 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032271: Wartner Wart Removal System, Model 66715 82000 (Product Code Number 52E022), Wartner USA B.V. (2003) Summary page 1.
- K031697: DR. Scholl's Freeze Away Wart Remover, Model 40226, Schering-Plough Healthcare Products, Inc. (2003) Summary page 1.
- K023487: Histofreezer Wart Removal System or Other Proprietary Name, OraSure Technologies, Inc. (2003) Summary page 1.
- K130599: Wart Freeze, Koninklijke Utermohlen NV (2013) Summary page 2.

## Most influential descendants
- K172373: Compound W Nitro-Freeze (2017), 3 descendants of its own
- K242932: Skin Clinic Nitro Clear Wart Remover (2025), 1 descendant of its own
- K253000: CryoFreeze Wart and Skin Tag Remover (2025), 0 descendants of its own
- K242288: Advanced Cryo Wart Remover (2025), 0 descendants of its own
- K242625: Freeze Point & Private Label Versions (2024), 0 descendants of its own

## Indications for use
Wartie® Wart Remover is indicated for the over-the-counter treatment of common warts and plantar warts for patients aged 4 years and older.

Source page: https://510kreport.com/device/K140314
Methodology: https://510kreport.com/methodology