# K101049: Wart Freeze

- Pathway: 510(k) (Traditional)
- Applicant: Koninklijke Utermohlen NV
- Decided: Jun 23, 2011 after 435 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.
10 later devices descend from it; 1 cites it directly.
0 of 16 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.
- (no number) Wartner Wart Removal System: named in the summary without a submission number
- (no number) Dr. Scholl's Freeze Away Wart Remover: named in the summary without a submission number
- (no number) Reliable Digital Thermometer II: named in the summary without a submission number

## Most influential descendants
- K130599: Wart Freeze (2013), 9 descendants of its own
- 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

## Indications for use
Wart Freeze is indicated for the removal of common and plantar warts.

Source page: https://510kreport.com/device/K101049
Methodology: https://510kreport.com/methodology