510(k) · Cleared
ClearedCompound W Freeze Off Wart Removal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OraSure Technologies, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Jul 18, 2006 as substantially equivalent to K023487 (OraSure Technologies, Inc., 2003) and 1 other predicate after a 112-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Jul 18, 2006
- Review
- 112 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K911420 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK060859 Compound W Freeze Off Wart Removal SystemOraSure Technologies, Inc. · 2006
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) | K060859 | Compound W Freeze Off Wart Removal System | OraSure Technologies, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 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 |
|---|---|---|---|
| * | K023487 | Histofreezer Wart Removal System or Other Proprietary NameSummary page 1…accessories (21 CFR 878.4350), Product Code GEH. 3. Device to Which SubstantialEquivalence Is Claimed: Compound W® Freeze Off TM Wart Removal System - K023487 Wartner Wart Removal System, by Wartner Medical Products - K01 1708 (labeling only) 4. Descriptionof Device:… | 2003 |
| * | K011708 | Modification to Wartner Wart Removal SystemSummary page 1…Which SubstantialEquivalence Is Claimed: Compound W® Freeze Off TM Wart Removal System - K023487 Wartner Wart Removal System, by Wartner Medical Products - K01 1708 (labeling only) 4. Descriptionof Device: The Compound W® Freeze OffTM Plantar Wart Removal System is a cryosurg… | 2002 |
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 15 years and passes through 2 companies; a new generation was cleared every 11.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 6 other devices also cite its predicate K023487.
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?
The Compound W® Freeze Off TM Plantar Wart Removal System is indicated for over-the-counter treatment of common and plantar warts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060859: Compound W Freeze Off 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/K060859
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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