510(k) · Cleared
ClearedHistofreezer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solarcare Technologies Corp,Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Jun 28, 1991 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 later devices descend from it.
- Decided
- Jun 28, 1991
- Review
- 88 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 2 citing it directly.
- This deviceK911420 HistofreezerSolarcare Technologies Corp,Inc. · 1991
- Descendant · cites it directly · 22 of its ownK023487 Histofreezer Wart Removal System or Other Proprietary NameOraSure Technologies, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 11 of its ownK031697 DR. Scholl's Freeze Away Wart Remover, Model 40226Schering-Plough Healthcare Products, Inc. · 2003
- Descendant · 2 generations on · 10 of its ownK101049 Wart FreezeKoninklijke Utermohlen NV · 2011
- Descendant · 3 generations on · 9 of its ownK130599 Wart FreezeKoninklijke Utermohlen NV · 2013
- 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
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 · 2 generations on11descendants
- K101049Wart FreezeKoninklijke Utermohlen NV · 2011 · 2 generations on10descendants
- K130599Wart FreezeKoninklijke Utermohlen NV · 2013 · 3 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911420 | Histofreezer | Solarcare Technologies Corp,Inc. | 1991 | — |
| +1 | K023487 | Histofreezer Wart Removal System or Other Proprietary Name | OraSure Technologies, Inc. | 2003 | 3 |
| +2 | K031697 | DR. Scholl's Freeze Away Wart Remover, Model 40226 | Schering-Plough Healthcare Products, Inc. | 2003 | — |
| +2 | K101049 | Wart Freeze | Koninklijke Utermohlen NV | 2011 | — |
| +3 | K130599 | Wart Freeze | Koninklijke Utermohlen NV | 2013 | — |
| +2 | K211099 | Freeze’n Clear Skin Clinic Warts & Tags | Cryoconcepts LP | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (23)
See all 232 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?
- Of its descendants, K023487 (OraSure Technologies, Inc., 2003) has gone furthest, with 22 descendants of its own.
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 | — |
https://510kreport.com/device/K911420 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911420: Histofreezer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911420
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026