510(k) · Cleared
ClearedWart Freeze
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koninklijke Utermohlen NV · GEH Unit, Cryosurgical, Accessories
Cleared on Jun 5, 2013 as substantially equivalent to K101049 (Koninklijke Utermohlen NV, 2011) after a 90-day review. Its family tree reaches back 3 generations to 1991. 9 later devices descend from it.
- Decided
- Jun 5, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K911420 (1991). 6 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK911420 HistofreezerSolarcare Technologies Corp,Inc. · 1991
- 2 generations backK023487 Histofreezer Wart Removal System or Other Proprietary NameOraSure Technologies, Inc. · 2003 · Recalled
- 1 generation backK101049 Wart FreezeKoninklijke Utermohlen NV · 2011
- This deviceK130599 Wart FreezeKoninklijke Utermohlen NV · 2013
- Descendant · cites it directly · 8 of its ownK140314 Wartie Wart RemoverYonmedical BV · 2014
- Descendant · 2 generations on · 3 of its ownK172373 Compound W Nitro-FreezeMedtech Products, Inc. · 2017
- Descendant · 3 generations on · 1 of its ownK242932 Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025
- Descendant · 4 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 · 2 generations on3descendants
- K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025 · 3 generations on1descendant
- K253000CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025 · 4 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 |
|---|---|---|---|---|---|
| −3 | K911420 | Histofreezer | Solarcare Technologies Corp,Inc. | 1991 | — |
| −2 | K023487 | Histofreezer Wart Removal System or Other Proprietary Name | OraSure Technologies, Inc. | 2003 | 3 |
| −1 | K101049 | Wart Freeze | Koninklijke Utermohlen NV | 2011 | — |
| 0 (this device) | K130599 | Wart Freeze | Koninklijke Utermohlen NV | 2013 | — |
| +1 | K140314 | Wartie Wart Remover | Yonmedical BV | 2014 | — |
| +2 | K172373 | Compound W Nitro-Freeze | Medtech Products, Inc. | 2017 | — |
| +3 | K242932 | Skin Clinic Nitro Clear Wart Remover | Cryoconcepts LP | 2025 | — |
| +4 | K253000 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025 | — |
| +2 | K242288 | Advanced Cryo Wart Remover | Medical Brands Laboratories B.V. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
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? (1)
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 |
|---|---|---|---|
| * | K101049 | Wart FreezeSummary page 1…hnology, method of application and materials for this 510k Special. Name of device Manufacturer Predicate 510(k) comparison Number Wart Freeze Koninklijke Intended use, K101049 Primary predicate Utermahlen technology, for changes materials Description of the device: Wart Freeze is a private label (priva… | 2011 |
What descends from it? (9)
2 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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 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. 2013, this device’s year, is highlighted.
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?
The product is indicated for the removal of common and plantar warts.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130599: Wart Freeze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130599
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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