510(k) · Cleared
ClearedWartner Wart Removal System, Model 66715 82000 (Product Code Number 52E022)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wartner USA B.V. · GEH Unit, Cryosurgical, Accessories
Cleared on Sep 10, 2003 after a 49-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Sep 10, 2003
- Review
- 49 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK032271 Wartner Wart Removal System, Model 66715 82000 (Product Code Number…Wartner USA B.V. · 2003
- Descendant · cites it directly · 8 of its ownK140314 Wartie Wart RemoverYonmedical BV · 2014
- Descendant · cites it directly · 3 of its ownK172373 Compound W Nitro-FreezeMedtech Products, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK242932 Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025
- Descendant · 3 generations on · 0 of its ownK253000 CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK242288 Advanced Cryo Wart RemoverMedical Brands Laboratories B.V. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K140314Wartie Wart RemoverYonmedical BV · 2014 · cites it directly8descendants
- K172373Compound W Nitro-FreezeMedtech Products, Inc. · 2017 · cites it directly3descendants
- K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025 · 2 generations on1descendant
- K253000CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025 · 3 generations on0descendants
- K242288Advanced Cryo Wart RemoverMedical Brands Laboratories B.V. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032271 | Wartner Wart Removal System, Model 66715 82000 (Product Code Number 52E022) | Wartner USA B.V. | 2003 | — |
| +1 | K140314 | Wartie Wart Remover | Yonmedical BV | 2014 | — |
| +1 | K172373 | Compound W Nitro-Freeze | Medtech Products, Inc. | 2017 | — |
| +2 | K242932 | Skin Clinic Nitro Clear Wart Remover | Cryoconcepts LP | 2025 | — |
| +3 | K253000 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025 | — |
| +2 | K242288 | Advanced Cryo Wart Remover | Medical Brands Laboratories B.V. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEH device
- #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Wartner® Wart Removal System for OTC use Named without a submission number | |
| * | — | Histofreezer® Portable Cryosurgical System Named without a submission number | |
| * | — | Tinamedo Plantar Patch Named without a submission number | |
| * | — | DuoFilm® Salicylic Acid Wart Remover indicated for common warts and plantar warts Named without a submission number | |
| * | — | Clear Away® System Plantar Wart Remover for Feet Named without a submission number | |
| * | — | Wartner Pro® Named without a submission number |
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K140314 (Yonmedical BV, 2014) has gone furthest, with 8 descendants of its own.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEH
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEH
77in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEH
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GEH
171in 2025
MAUDE reports naming product code GEH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 71 | 3 | 23 |
| 2008 | 1 | — | 2 | 29 |
| 2009 | 4 | 121 | 13 | 21 |
| 2010 | 4 | 86 | 4 | 173 |
| 2011 | 7 | 91 | 0 | 61 |
| 2012 | 4 | 96 | 3 | 91 |
| 2013 | 4 | 76 | 0 | 91 |
| 2014 | 6 | 42 | 2 | 57 |
| 2015 | 11 | 72 | 0 | 97 |
| 2016 | 15 | 60 | 0 | 143 |
| 2017 | 12 | 83 | 0 | 216 |
| 2018 | 6 | 42 | 1 | 208 |
| 2019 | 6 | 115 | 1 | 455 |
| 2020 | 8 | 113 | 37 | 277 |
| 2021 | 6 | 206 | 0 | 213 |
| 2022 | 6 | 56 | 0 | 230 |
| 2023 | 8 | 136 | 2 | 164 |
| 2024 | 9 | 85 | 0 | 141 |
| 2025 | 10 | 77 | 0 | 171 |
| 2026 | 8 | 148 | 2 | — |
What is it indicated for?
WARTNER' Wart Removal System is indicated for the over-the-counter treatment of common warts and plantar warts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032271 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032271: Wartner Wart Removal System, Model 66715 82000 (Product Code Number 52E022).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032271
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026