# K032271: Wartner Wart Removal System, Model 66715 82000 (Product Code Number 52E022)

- Pathway: 510(k) (Traditional)
- Applicant: Wartner USA B.V.
- Decided: Sep 10, 2003 after 49 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
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Wartner® Wart Removal System for OTC use: named in the summary without a submission number
- (no number) Histofreezer® Portable Cryosurgical System: named in the summary without a submission number
- (no number) Tinamedo Plantar Patch: named in the summary without a submission number
- (no number) DuoFilm® Salicylic Acid Wart Remover indicated for common warts and plantar warts: named in the summary without a submission number
- (no number) Clear Away® System Plantar Wart Remover for Feet: named in the summary without a submission number
- (no number) Wartner Pro®: named in the summary without a submission number

## 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
- K253000: CryoFreeze Wart and Skin Tag Remover (2025), 0 descendants of its own
- K242288: Advanced Cryo Wart Remover (2025), 0 descendants of its own

## Indications for use
WARTNER' Wart Removal System is indicated for the over-the-counter treatment of common warts and plantar warts.

Source page: https://510kreport.com/device/K032271
Methodology: https://510kreport.com/methodology