510(k) · Cleared
ClearedVerruca-Freeze Cryosurgery Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryosurgery, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Jan 27, 1999 after a 191-day review. The FDA summary names no predicate by number. 19 later devices descend from it.
- Decided
- Jan 27, 1999
- Review
- 191 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 3 citing it directly.
- This deviceK982506 Verruca-Freeze Cryosurgery Delivery SystemCryosurgery, Inc. · 1999
- Descendant · cites it directly · 16 of its ownK130995 Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze SprayNuance Medical, LLC · 2013
- Descendant · 2 generations on · 12 of its ownK161296 Cool RenewalCool Renewal, LLC · 2016
- Descendant · 3 generations on · 9 of its ownK190747 ClaritagDgi Technologies · 2019
- Descendant · 4 generations on · 8 of its ownK211099 Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP · 2022
- Descendant · 5 generations on · 1 of its ownK242932 Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K130995Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze SprayNuance Medical, LLC · 2013 · cites it directly16descendants
- K161296Cool RenewalCool Renewal, LLC · 2016 · 2 generations on12descendants
- K190747ClaritagDgi Technologies · 2019 · 3 generations on9descendants
- K211099Freeze’n Clear Skin Clinic Warts & TagsCryoconcepts LP · 2022 · 4 generations on8descendants
- K242932Skin Clinic Nitro Clear Wart RemoverCryoconcepts LP · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982506 | Verruca-Freeze Cryosurgery Delivery System | Cryosurgery, Inc. | 1999 | — |
| +1 | K130995 | Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze Spray | Nuance Medical, LLC | 2013 | — |
| +2 | K161296 | Cool Renewal | Cool Renewal, LLC | 2016 | — |
| +3 | K190747 | Claritag | Dgi Technologies | 2019 | — |
| +4 | K211099 | Freeze’n Clear Skin Clinic Warts & Tags | Cryoconcepts LP | 2022 | — |
| +5 | K242932 | Skin Clinic Nitro Clear Wart Remover | Cryoconcepts LP | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (19)
See all 193 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, K130995 (Nuance Medical, LLC, 2013) has gone furthest, with 16 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 | — |
What is it indicated for?
1,1,1,2-tetrafluoroethane, pentafluoroethane, and 1,1,1-trifluoroethane is to be used for
the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic
keratoses, achrochordon, molluscum contagiosum, age spots, dermatofibroma, small
keloids, granuloma annulare, porokeratosis plantaris, angiomas, lentigo maligna,
keratoacanthoma, basal cell, bowen’s disease, lentigo discreta, chondrodermatitis,
epithelial nevus, leukoplakia, granuloma pyogenicum, kaposi’s sarcoma, and pyogenic
granuloma.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982506: Verruca-Freeze Cryosurgery Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982506
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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