510(k) · Cleared
ClearedCryopro Maxi and Cryopro Mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cortex Technology Aps · GEH Unit, Cryosurgical, Accessories
Cleared on Nov 25, 1998 after a 148-day review. The FDA summary names its predicate without a number. 18 later devices descend from it.
- Decided
- Nov 25, 1998
- Review
- 148 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 3 citing it directly.
- This deviceK982280 Cryopro Maxi and Cryopro MiniCortex Technology Aps · 1998
- Descendant · cites it directly · 16 of its ownK040809 Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004
- Descendant · cites it directly · 15 of its ownK060555 Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006
- Descendant · 2 generations on · 13 of its ownK070893 Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc. · 2007
- Descendant · 2 generations on · 11 of its ownK101825 Cryoballoon Ablation SystemC2 Therapeutics · 2010
- Descendant · 3 generations on · 10 of its ownK131523 Cryoballoon Focal Ablation SystemC2 Therapeutics · 2013 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K040809Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004 · cites it directly16descendants
- K060555Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006 · cites it directly15descendants
- K070893Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc. · 2007 · 2 generations on13descendants
- K101825Cryoballoon Ablation SystemC2 Therapeutics · 2010 · 2 generations on11descendants
- K131523Cryoballoon Focal Ablation SystemC2 Therapeutics · 2013 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982280 | Cryopro Maxi and Cryopro Mini | Cortex Technology Aps | 1998 | — |
| +1 | K040809 | Crymed Cryo-Ablator | Crymed Technologies, Inc. | 2004 | — |
| +1 | K060555 | Spraygenix Cryo Ablation System | Crymed Technologies, Inc. | 2006 | — |
| +2 | K070893 | Cryospray Ablation System, Model CU 8407020500 | CSA Medical, Inc. | 2007 | — |
| +2 | K101825 | Cryoballoon Ablation System | C2 Therapeutics | 2010 | — |
| +3 | K131523 | Cryoballoon Focal Ablation System | C2 Therapeutics | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | — | CryoGun® liquid nitrogen cryosurgical system Named without a submission number |
What descends from it? (18)
See all 183 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, K040809 (Crymed Technologies, Inc., 2004) 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?
The CryoPro® Mini and CryoPro® Maxi units are intended to be used within the fields of dermatology and plastic surgery for the treatment of cryoresponsive benign, premalignant and malignant tumors such as skin tags, verrucae, actinic keratoses and basal cell carcinoma.
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/K982280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982280: Cryopro Maxi and Cryopro Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982280
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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