510(k) · Cleared
ClearedDR. Scholl's Freeze Away Wart Remover, Model 40226
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schering-Plough Healthcare Products, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Aug 29, 2003 as substantially equivalent to K011708 (Wartner Medical Products, 2002) and 2 other predicates after an 88-day review. Its family tree reaches back 2 generations to 1991. 11 later devices descend from it.
- Decided
- Aug 29, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K911420 (1991). 5 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK911420 HistofreezerSolarcare Technologies Corp,Inc. · 1991
- 1 generation backK023487 Histofreezer Wart Removal System or Other Proprietary NameOraSure Technologies, Inc. · 2003 · Recalled
- This deviceK031697 DR. Scholl's Freeze Away Wart Remover, Model 40226Schering-Plough Healthcare Products, Inc. · 2003
- 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 · cites it directly · 1 of its ownK052259 DR. Scholl's Dual Action Freeze Away Wart Remover, Model 40406Schering-Plough Healthcare Products, Inc. · 2005
- Descendant · 4 generations on · 0 of its ownK253000 CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · 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
- K052259DR. Scholl's Dual Action Freeze Away Wart Remover, Model 40406Schering-Plough Healthcare Products, Inc. · 2005 · cites it directly1descendant
- K253000CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911420 | Histofreezer | Solarcare Technologies Corp,Inc. | 1991 | — |
| −1 | K023487 | Histofreezer Wart Removal System or Other Proprietary Name | OraSure Technologies, Inc. | 2003 | 3 |
| 0 (this device) | K031697 | DR. Scholl's Freeze Away Wart Remover, Model 40226 | Schering-Plough Healthcare Products, Inc. | 2003 | — |
| +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 | — |
| +1 | K052259 | DR. Scholl's Dual Action Freeze Away Wart Remover, Model 40406 | Schering-Plough Healthcare Products, Inc. | 2005 | — |
| +4 | K253000 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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? (3)
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 |
|---|---|---|---|
| * | K011708 | Modification to Wartner Wart Removal System | 2002 |
| * | K023487 | Histofreezer Wart Removal System or Other Proprietary NameSummary page 1…moval System, by Wartner Medical Products (Primary Predicate) - KO 1 1708 Histofreezer Wart Removal System, by OraSure Technologies, Inc. (Plantar Wart Claim) - K023487, K924114 4. Description of Device: Dr. Scholl’s Freeze Away Wart Remover is a cryosurgical system for the over-the- counte… | 2003 |
| * | K924114 | HistofreezerSummary page 1…tem, by Wartner Medical Products (Primary Predicate) - KO 1 1708 Histofreezer Wart Removal System, by OraSure Technologies, Inc. (Plantar Wart Claim) - K023487, K924114 4. Description of Device: Dr. Scholl’s Freeze Away Wart Remover is a cryosurgical system for the over-the- counter removal… | 1993 |
What descends from it? (11)
See all 112 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 12 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K140314 (Yonmedical BV, 2014) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K011708.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For the over-the-counter removal of common warts and plantar warts on the bottom of the foot.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031697 · printed Nov 4, 2026
Cite this page
510(k) Report. “K031697: DR. Scholl's Freeze Away Wart Remover, Model 40226.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031697
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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