510(k) Report

510(k) · Cleared

Cleared

Modification to Wartner Wart Removal System

K011708510(k) TraditionalCleared Feb 20, 2002261-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

Wartner Medical Products · GEH Unit, Cryosurgical, Accessories

Cleared on Feb 20, 2002 after a 261-day review. The FDA summary names its predicate without a number. 23 later devices descend from it.

Decided
Feb 20, 2002
Review
261 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
0

23 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2003: 2 descendants cleared2011: 2 descendants cleared2015: 1 descendant cleared2022: 1 descendant cleared2014: 1 descendant cleared2005: 1 descendant cleared2013: 1 descendant cleared2016: 1 descendant cleared2021: 2 descendants cleared2024: 3 descendants cleared2017: 1 descendant cleared2025: 4 descendants cleared2023: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK011708 Modification to Wartner Wart Removal SystemWartner Medical Products · 2002
  2. Descendant · cites it directly · 22 of its ownK023487 Histofreezer Wart Removal System or Other Proprietary NameOraSure Technologies, Inc. · 2003 · Recalled
  3. Descendant · cites it directly · 11 of its ownK031697 DR. Scholl's Freeze Away Wart Remover, Model 40226Schering-Plough Healthcare Products, Inc. · 2003
  4. Descendant · cites it directly · 10 of its ownK101049 Wart FreezeKoninklijke Utermohlen NV · 2011
  5. Descendant · 2 generations on · 9 of its ownK130599 Wart FreezeKoninklijke Utermohlen NV · 2013
  6. Descendant · 2 generations on · 8 of its ownK211099 Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP · 2022

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2003: 22005: 12006: 12011: 22013: 12014: 12015: 12016: 12017: 12021: 22022: 12023: 12024: 32025: 42026: 1
2003high 4 (2025) · low 0 (2004)2026

Most influential descendants

Showing 5 of 23 · See all
  • K023487Histofreezer Wart Removal System or Other Proprietary NameOraSure Technologies, Inc. · 2003 · cites it directly22descendants
  • K031697DR. Scholl's Freeze Away Wart Remover, Model 40226Schering-Plough Healthcare Products, Inc. · 2003 · cites it directly11descendants
  • K101049Wart FreezeKoninklijke Utermohlen NV · 2011 · cites it directly10descendants
  • K130599Wart FreezeKoninklijke Utermohlen NV · 2013 · 2 generations on9descendants
  • K211099Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP · 2022 · 2 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011708Modification to Wartner Wart Removal SystemWartner Medical Products2002—
+1K023487Histofreezer Wart Removal System or Other Proprietary NameOraSure Technologies, Inc.20033
+1K031697DR. Scholl's Freeze Away Wart Remover, Model 40226Schering-Plough Healthcare Products, Inc.2003—
+1K101049Wart FreezeKoninklijke Utermohlen NV2011—
+2K130599Wart FreezeKoninklijke Utermohlen NV2013—
+2K211099Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200510
200610
201120
201310
201410
201510
201610
201710
202120
202210
202310
202430
202540
202610
FIG. 1 — Lineage of K011708, 2002–2026Source: 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? (7)

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
*—Wartner Wart Removal System
Named without a submission number
—
*—Compound W Gel
Named without a submission number
—
*—Compound W Pads for Kids
Named without a submission number
—
*—Clear Away Gel
Named without a submission number
—
*—Clear Away Liquid
Named without a submission number
—
*—Rite Aid Wart Liquid
Named without a submission number
—
*—Suave Hairspray
Named without a submission number
—

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K023487Histofreezer Wart Removal System or Other Proprietary NameOraSure Technologies, Inc.200322
K031697DR. Scholl's Freeze Away Wart Remover, Model 40226Schering-Plough Healthcare Products, Inc.200311
K101049Wart FreezeKoninklijke Utermohlen NV201110
K060859Compound W Freeze Off Wart Removal SystemOraSure Technologies, Inc.20060

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, K023487 (OraSure Technologies, Inc., 2003) has gone furthest, with 22 descendants of its own.

How does its category compare?

All GEH devices

GEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

Wartner Wart Removal System is intended for the treatment of common warts.

Indications for use as stated in the FDA summary.

More from Wartner Medical Products

3 FDA decisions under this applicant name. See the company

  • K030838Wartner ProWartner Medical Products · 2003
  • K002714Wartner Wart Removal SystemWartner Medical Products · 2000

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/K011708 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011708: Modification to Wartner Wart Removal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011708

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026