510(k) Report

510(k) · Cleared

Cleared

Wartie Wart Remover

K140314510(k) TraditionalCleared Jun 12, 2014122-day reviewClass II21 CFR 878.4350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Yonmedical BV · GEH Unit, Cryosurgical, Accessories

Cleared on Jun 12, 2014 as substantially equivalent to K032271 (Wartner USA B.V., 2003) and 3 other predicates after a 122-day review. Its family tree reaches back 4 generations to 1991. 8 later devices descend from it.

Decided
Jun 12, 2014
Review
122 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K911420 (1991). 9 ancestors in all. 8 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors2002: 1 other ancestor1997: 1 other ancestor1993: 1 other ancestor2015: 1 descendant cleared2024: 1 descendant cleared2021: 2 descendants cleared2017: 1 descendant cleared2025: 3 descendants clearedK911420 · Histofreezer · Solarcare Technologies Corp,Inc. · 1991K023487 · Histofreezer Wart Removal System or Other Proprietary Name · OraSure Technologies, Inc. · 2003 · recalledK101049 · Wart Freeze · Koninklijke Utermohlen NV · 2011K130599 · Wart Freeze · Koninklijke Utermohlen NV · 20131990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors 1 generation forward: 6 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K130599 · Wart Freeze · Koninklijke Utermohlen NV · 2013K101049 · Wart Freeze · Koninklijke Utermohlen NV · 2011K023487 · Histofreezer Wart Removal System or Other Proprietary Name · OraSure Technologies, Inc. · 2003 · recalledK911420 · Histofreezer · Solarcare Technologies Corp,Inc. · 19910
  1. Root · 4 generations backK911420 HistofreezerSolarcare Technologies Corp,Inc. · 1991
  2. 3 generations backK023487 Histofreezer Wart Removal System or Other Proprietary NameOraSure Technologies, Inc. · 2003 · Recalled
  3. 2 generations backK101049 Wart FreezeKoninklijke Utermohlen NV · 2011
  4. 1 generation backK130599 Wart FreezeKoninklijke Utermohlen NV · 2013
  5. This deviceK140314 Wartie Wart RemoverYonmedical BV · 2014
  6. Descendant · cites it directly · 3 of its ownK172373 Compound W Nitro-FreezeMedtech Products, Inc. · 2017
  7. Descendant · 2 generations on · 1 of its ownK242932 Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025
  8. Descendant · 3 generations on · 0 of its ownK253000 CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025
  9. Descendant · cites it directly · 0 of its ownK242288 Advanced Cryo Wart RemoverMedical Brands Laboratories B.V. · 2025
  10. Descendant · cites it directly · 0 of its ownK242625 Freeze Point & Private Label VersionsCryoconcepts LP · 2024

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2015: 12017: 12021: 22024: 12025: 3
2015high 3 (2025) · low 0 (2016)2026

Most influential descendants

Showing 5 of 8 · See all
  • 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 · cites it directly0descendants
  • K242625Freeze Point & Private Label VersionsCryoconcepts LP · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K911420HistofreezerSolarcare Technologies Corp,Inc.1991—
−3K023487Histofreezer Wart Removal System or Other Proprietary NameOraSure Technologies, Inc.20033
−2K101049Wart FreezeKoninklijke Utermohlen NV2011—
−1K130599Wart FreezeKoninklijke Utermohlen NV2013—
0 (this device)K140314Wartie Wart RemoverYonmedical BV2014—
+1K172373Compound W Nitro-FreezeMedtech Products, Inc.2017—
+2K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP2025—
+3K253000CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc.2025—
+1K242288Advanced Cryo Wart RemoverMedical Brands Laboratories B.V.2025—
+1K242625Freeze Point & Private Label VersionsCryoconcepts LP2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199710
200210
200320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201710
202120
202410
202530
FIG. 1 — Lineage of K140314, 1991–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K032271Wartner Wart Removal System, Model 66715 82000 (Product Code Number 52E022)
Summary page 1
…Comparison Number, Wartner®8 Wartner US Intended K032271 Wart b.v use, Removal -technology, System…
Wartner USA B.V.2003—
*K031697DR. Scholl's Freeze Away Wart Remover, Model 40226
Summary page 1
…label. Dr. Scholl's® Schering- Intended K031697 Freeze Plough use, AwayTM Healthcare…
Schering-Plough Healthcare Products, Inc.2003—
*K023487Histofreezer Wart Removal System or Other Proprietary Name
Summary page 1
…over label. Histofreezer® OraSure' Intended K023487 Wart Technologies, use, Removal Inc.…
OraSure Technologies, Inc.20033
*K130599Wart Freeze
Summary page 2
…Date: 06-June-14 Wart Freeze Koninklijke Intended K130599 Utermdhlen use, N.V. technology,…
Koninklijke Utermohlen NV2013—

Also cleared against K032271: 2 other devices →

What descends from it? (8)

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K172373Compound W Nitro-FreezeMedtech Products, Inc.20173
K242288Advanced Cryo Wart RemoverMedical Brands Laboratories B.V.20250
K242625Freeze Point & Private Label VersionsCryoconcepts LP20240
K210529Dr. Yglo Wart RemoverTheotclab Healthcare B.V.20210
K201366ForwartsPronova Laboratories BV20210
K151309Wartie Advanced Wart Remover or other proprietary nameYoumedical Corp BV20150

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 23 years and passes through 4 companies; a new generation was cleared every 8.3 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • Of its descendants, K172373 (Medtech Products, Inc., 2017) has gone furthest, with 3 descendants of its own.
  • 2 other devices also cite its predicate K032271.

How does its category compare?

All GEH devices

GEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · GEH

10in 2025

2007: 62008: 12009: 42010: 42011: 72012: 42013: 42014: 62015: 112016: 152017: 122018: 62019: 62020: 82021: 62022: 62023: 82024: 92025: 102026 (partial year): 8
2007high 15 (2016) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEH

77in 2025

2007: 71 days median2009: 121 days median2010: 86 days median2011: 91 days median2012: 96 days median2013: 76 days median2014: 42 days median2015: 72 days median2016: 60 days median2017: 83 days median2018: 42 days median2019: 115 days median2020: 113 days median2021: 206 days median2022: 56 days median2023: 136 days median2024: 85 days median2025: 77 days median2026 (partial year): 148 days median
2007high 206 (2021) · low 42 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEH

2in 2023

2007: 32008: 22009: 132010: 42012: 32014: 22018: 12019: 12020: 372023: 22026 (partial year): 2
2007high 37 (2020) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEH

171in 2025

2007: 232008: 292009: 212010: 1732011: 612012: 912013: 912014: 572015: 972016: 1432017: 2162018: 2082019: 4552020: 2772021: 2132022: 2302023: 1642024: 1412025: 171
2007high 455 (2019) · low 21 (2009)2025

MAUDE reports naming product code GEH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007671323
20081—229
200941211321
20104864173
2011791061
2012496391
2013476091
2014642257
20151172097
201615600143
201712830216
20186421208
201961151455
2020811337277
202162060213
20226560230
202381362164
20249850141
202510770171
202681482—

What is it indicated for?

Wartie® Wart Remover is indicated for the over-the-counter treatment of common warts and plantar warts for patients aged 4 years and older.

Indications for use as stated in the FDA summary.

Also cleared against K032271

2 other devices cite the same predicate.

  • K201366ForwartsPronova Laboratories BV · 2021
  • K172373Compound W Nitro-FreezeMedtech Products, Inc. · 2017

Recent decisions in GEH

The GEH category page

  • K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical · 2026
  • K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical · 2026
  • K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH · 2026
  • K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH · 2026
  • K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V. · 2026

https://510kreport.com/device/K140314 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140314: Wartie 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/K140314

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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