510(k) Report

510(k) · Cleared

Recalled · Class III · 2020

Histofreezer Wart Removal System or Other Proprietary Name

K023487510(k) TraditionalCleared Mar 20, 2003154-day reviewClass II21 CFR 878.4350Recalls 3

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

OraSure Technologies, Inc. · GEH Unit, Cryosurgical, Accessories

Cleared on Mar 20, 2003 as substantially equivalent to K911420 (Solarcare Technologies Corp,Inc., 1991) and 3 other predicates after a 154-day review. Its family tree reaches back 1 generation to 1991. 22 later devices descend from it. It has been recalled 3 times.

Decided
Mar 20, 2003
Review
154 days
Class
Class II
Product code
GEH
Recalls
3
Predicates
4

Its longest line of descent runs back 1 generation to K911420 (1991). 4 ancestors in all. 22 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1997: 1 other ancestor1993: 1 other ancestor2006: 1 descendant cleared2015: 1 descendant cleared2022: 1 descendant cleared2011: 2 descendants cleared2003: 1 descendant cleared2014: 1 descendant cleared2005: 1 descendant cleared2013: 1 descendant cleared2024: 3 descendants cleared2021: 2 descendants cleared2017: 1 descendant cleared2025: 4 descendants cleared2023: 1 descendant cleared2026: 1 descendant cleared2016: 1 descendant clearedK911420 · Histofreezer · Solarcare Technologies Corp,Inc. · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 7 descendants2 generations forward: 13 descendants3 generations forward: 2 descendants K911420 · Histofreezer · Solarcare Technologies Corp,Inc. · 19910
  1. Root · 1 generation backK911420 HistofreezerSolarcare Technologies Corp,Inc. · 1991
  2. This deviceK023487 Histofreezer Wart Removal System or Other Proprietary NameOraSure Technologies, Inc. · 2003
  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 · cites it directly · 8 of its ownK211099 Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP · 2022
  7. Descendant · cites it directly · 8 of its ownK140314 Wartie Wart RemoverYonmedical BV · 2014

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2003: 12005: 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 22 · See all
  • 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 · cites it directly8descendants
  • K140314Wartie Wart RemoverYonmedical BV · 2014 · cites it directly8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K911420HistofreezerSolarcare Technologies Corp,Inc.1991—
0 (this device)K023487Histofreezer Wart Removal System or Other Proprietary NameOraSure Technologies, Inc.2003—
+1K031697DR. Scholl's Freeze Away Wart Remover, Model 40226Schering-Plough Healthcare Products, Inc.2003—
+1K101049Wart FreezeKoninklijke Utermohlen NV2011—
+2K130599Wart FreezeKoninklijke Utermohlen NV2013—
+1K211099Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP2022—
+1K140314Wartie Wart RemoverYonmedical BV2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199710
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200610
201120
201310
201410
201510
201610
201710
202120
202210
202310
202430
202540
202610
FIG. 1 — Lineage of K023487, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (8)

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
*K911420Histofreezer
Summary page 1
…surgical unit, accessories 3. Device to Which Substantial Equivalence Is Claimed: Histofreezer@ Device, by OraSure Technologies, Inc. (Primary Predicate) - K911420, K924 1 14, K97 1392 Wartner Wart Removal System, by Wartner Medical Products (OTC claim) - KO1 1708 Comp…
Solarcare Technologies Corp,Inc.1991—
*K924114Histofreezer
Summary page 1
…cessories 3. Device to Which Substantial Equivalence Is Claimed: Histofreezer@ Device, by OraSure Technologies, Inc. (Primary Predicate) - K911420, K924 1 14, K97 1392 Wartner Wart Removal System, by Wartner Medical Products (OTC claim) - KO1 1708 Compound W Gel, by Medt…
Solarcare Technologies Corp,Inc.1993—
*K971392Histofreezer Verruca Plana
Summary page 1
…3. Device to Which Substantial Equivalence Is Claimed: Histofreezer@ Device, by OraSure Technologies, Inc. (Primary Predicate) - K911420, K924 1 14, K97 1392 Wartner Wart Removal System, by Wartner Medical Products (OTC claim) - KO1 1708 Compound W Gel, by Medtech (label…
OraSure Technologies, Inc.1997—
*K011708Modification to Wartner Wart Removal SystemWartner Medical Products2002—
*—Compound W Gel
Named without a submission number
—
*—Clear Away Liquid
Named without a submission number
—
*—Clear Away One Step for Kids
Named without a submission number
—
*—Rite Aid Wart Liquid
Named without a submission number
—

Also cleared against K911420: 1 other device →

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K031697DR. Scholl's Freeze Away Wart Remover, Model 40226Schering-Plough Healthcare Products, Inc.200311
K101049Wart FreezeKoninklijke Utermohlen NV201110
K211099Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP20228
K140314Wartie Wart RemoverYonmedical BV20148
K151309Wartie Advanced Wart Remover or other proprietary nameYoumedical Corp BV20150
K103310Cryonize TM3jt Enterprises, LLC20110
K060859Compound W Freeze Off Wart Removal SystemOraSure Technologies, Inc.20060

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 15, 2020Class IIIZ-3002-2020Under Investigation by firmUnit boxes not properly sealed
Jul 15, 2020Class IIIZ-3003-2020Under Investigation by firmUnit boxes not properly sealed
Jul 15, 2020Class IIIZ-3001-2020Under Investigation by firmUnit boxes not properly sealed

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K031697 (Schering-Plough Healthcare Products, Inc., 2003) has gone furthest, with 11 descendants of its own.
  • 1 other device also cites its predicate K911420.

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?

The Histofreezer® Wart Removal System is indicated for over-the-counter treatment 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.

Also cleared against K911420

1 other device cites the same predicate.

  • K103310Cryonize TM3jt Enterprises, LLC · 2011

More from OraSure Technologies, Inc.

66 FDA decisions under this applicant name. See the company

  • P080027/S039OraQuick HCV Rapid Antibody TestOraSure Technologies, Inc. · 2021
  • P080027/S038OraQuick HCV Rapid Antibody TestOraSure Technologies, Inc. · 2021
  • P080027/S037OraQuick HCV Rapid Antibody TestOraSure Technologies, Inc. · 2020
  • DEN190025OraQuick Ebola Rapid Antigen TestOraSure Technologies, Inc. · 2019
  • P080027/S035OraQuick HCV Rapid Antibody TestOraSure Technologies, Inc. · 2019

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/K023487 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023487: Histofreezer Wart Removal System or Other Proprietary Name.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023487

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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