510(k) · Cleared
ClearedCompound W Nitro-Freeze
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtech Products, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Nov 2, 2017 as substantially equivalent to K032271 (Wartner USA B.V., 2003) and 1 other predicate after an 87-day review. Its family tree reaches back 5 generations to 1991. 3 later devices descend from it.
- Decided
- Nov 2, 2017
- Review
- 87 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K911420 (1991). 10 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK911420 HistofreezerSolarcare Technologies Corp,Inc. · 1991
- 4 generations backK023487 Histofreezer Wart Removal System or Other Proprietary NameOraSure Technologies, Inc. · 2003 · Recalled
- 3 generations backK101049 Wart FreezeKoninklijke Utermohlen NV · 2011
- 2 generations backK130599 Wart FreezeKoninklijke Utermohlen NV · 2013
- 1 generation backK140314 Wartie Wart RemoverYonmedical BV · 2014
- This deviceK172373 Compound W Nitro-FreezeMedtech Products, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK242932 Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025
- Descendant · 2 generations on · 0 of its ownK253000 CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK201366 ForwartsPronova Laboratories BV · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911420 | Histofreezer | Solarcare Technologies Corp,Inc. | 1991 | — |
| −4 | K023487 | Histofreezer Wart Removal System or Other Proprietary Name | OraSure Technologies, Inc. | 2003 | 3 |
| −3 | K101049 | Wart Freeze | Koninklijke Utermohlen NV | 2011 | — |
| −2 | K130599 | Wart Freeze | Koninklijke Utermohlen NV | 2013 | — |
| −1 | K140314 | Wartie Wart Remover | Yonmedical BV | 2014 | — |
| 0 (this device) | K172373 | Compound W Nitro-Freeze | Medtech Products, Inc. | 2017 | — |
| +1 | K242932 | Skin Clinic Nitro Clear Wart Remover | Cryoconcepts LP | 2025 | — |
| +2 | K253000 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025 | — |
| +1 | K201366 | Forwarts | Pronova Laboratories BV | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K032271 | Wartner Wart Removal System, Model 66715 82000 (Product Code Number 52E022)Summary page 4…II Classification Panel: General & Plastic Surgery Devices 4. Legally Marketed Predicate Device(s) Predicate No. 1: Wartner® Wart Removal System (K032271), Product Code GEH Predicate No. 2: Wartie® Wart Remover (K140314), Product Code GEH… | 2003 |
| * | K140314 | Wartie Wart RemoverSummary page 4…Marketed Predicate Device(s) Predicate No. 1: Wartner® Wart Removal System (K032271), Product Code GEH Predicate No. 2: Wartie® Wart Remover (K140314), Product Code GEH MEDTECH PRODUCTS INC. 660 WHITE PLAINS R… | 2014 |
| † | K130599 | Wart Freeze | 2013 |
What descends from it? (3)
2 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 26 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K242932 (Cryoconcepts LP, 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K032271.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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?
Compound W® Nitro-Freeze is intended for over-the-counter treatment of common warts and plantar warts in adults and children four years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172373: Compound W Nitro-Freeze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172373
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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