510(k) Report

510(k) · Cleared

Cleared

Histofreezer

K933327510(k) TraditionalCleared Oct 29, 1993113-day reviewClass II21 CFR 878.4350

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

Solarcare, Inc. · GEH Unit, Cryosurgical, Accessories

Cleared on Oct 29, 1993 after a 113-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it.

Decided
Oct 29, 1993
Review
113 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
0

10 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2022: 1 descendant cleared2011: 1 descendant cleared2024: 3 descendants cleared2023: 1 descendant cleared2026: 1 descendant cleared2025: 3 descendants cleared1990200020102020
  1. This deviceK933327 HistofreezerSolarcare, Inc. · 1993
  2. Descendant · cites it directly · 8 of its ownK211099 Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP · 2022
  3. Descendant · 2 generations on · 1 of its ownK242932 Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025
  4. Descendant · 2 generations on · 1 of its ownK243487 CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025
  5. Descendant · 2 generations on · 1 of its ownK240226 Pixie Skin TagOystershell NV · 2024
  6. Descendant · 2 generations on · 0 of its ownK252198 Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V. · 2026

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2011: 12022: 12023: 12024: 32025: 32026: 1
2011high 3 (2024) · low 0 (2012)2026

Most influential descendants

Showing 5 of 10 · See all
  • K211099Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP · 2022 · cites it directly8descendants
  • K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025 · 2 generations on1descendant
  • K243487CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc. · 2025 · 2 generations on1descendant
  • K240226Pixie Skin TagOystershell NV · 2024 · 2 generations on1descendant
  • K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933327HistofreezerSolarcare, Inc.1993—
+1K211099Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP2022—
+2K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP2025—
+2K243487CryoFreeze Wart and Skin Tag RemoverCryosurgery, Inc.2025—
+2K240226Pixie Skin TagOystershell NV2024—
+2K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
202210
202310
202430
202530
202610
FIG. 1 — Lineage of K933327, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K211099Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP20228
K103310Cryonize TM3jt Enterprises, LLC20110

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, K211099 (Cryoconcepts LP, 2022) has gone furthest, with 8 descendants of its own.

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—

More from Solarcare, Inc.

6 FDA decisions under this applicant name. See the company

  • K934775STC Cocaine Metabolite EiaSolarcare, Inc. · 1995
  • K944372STC Diagnostic Auto-Lyte Propoxyphene EiaSolarcare, Inc. · 1995
  • K941496Solarcare Total Protein Micro-Plate AssaySolarcare, Inc. · 1994
  • K941497Solarcare Alanine Aminotransferase Micro-Plate AssaySolarcare, Inc. · 1994
  • K934376STC Diagnostics Auto-Lyte Barbiturates EiaSolarcare, Inc. · 1993

Recent decisions in GEH

The GEH category page

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  • 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/K933327 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933327: Histofreezer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933327

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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