510(k) · Cleared
ClearedAdvanced Cryo Wart Remover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Brands Laboratories B.V. · GEH Unit, Cryosurgical, Accessories
Cleared on Jan 21, 2025 as substantially equivalent to K140314 (Yonmedical BV, 2014) after a 172-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Jan 21, 2025
- Review
- 172 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K911420 (1991). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK911420 HistofreezerSolarcare Technologies Corp,Inc. · 1991
- 4 generations backK023487 Histofreezer Wart Removal System or Other Proprietary NameOraSure Technologies, Inc. · 2003 · Recalled
- 3 generations backK101049 Wart FreezeKoninklijke Utermohlen NV · 2011
- 2 generations backK130599 Wart FreezeKoninklijke Utermohlen NV · 2013
- 1 generation backK140314 Wartie Wart RemoverYonmedical BV · 2014
- This deviceK242288 Advanced Cryo Wart RemoverMedical Brands Laboratories B.V. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911420 | Histofreezer | Solarcare Technologies Corp,Inc. | 1991 | — |
| −4 | K023487 | Histofreezer Wart Removal System or Other Proprietary Name | OraSure Technologies, Inc. | 2003 | 3 |
| −3 | K101049 | Wart Freeze | Koninklijke Utermohlen NV | 2011 | — |
| −2 | K130599 | Wart Freeze | Koninklijke Utermohlen NV | 2013 | — |
| −1 | K140314 | Wartie Wart Remover | Yonmedical BV | 2014 | — |
| 0 (this device) | 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 |
| 2003 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K140314 | Wartie Wart RemoverSummary page 5…y marketed Primary predicate device: Device Name: Wartie® Proprietary Name: Wartie® Wart Remover 510 (k) number: K140314 Manufacturer: YouMedical BV… | 2014 |
| * | — | Dr. Scholl’s Skin Tag Remover Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 5 companies; a new generation was cleared every 8.3 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 5 other devices also cite its predicate K140314.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Advanced Cryo Wart Remover is designed as an over-the-counter (OTC) self-care device indicated for adults and children from the age of four years and older for the treatment of common and plantar warts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242288: Advanced Cryo Wart Remover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242288
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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