510(k) · Cleared
ClearedCryopen Cryosurgical System, K102214
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryopen, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Sep 9, 2011 as substantially equivalent to K803311 (Wallach Surgical Devices, Inc., 1981) after a 175-day review. Its family tree reaches back 1 generation to 1981. 6 later devices descend from it.
- Decided
- Sep 9, 2011
- Review
- 175 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K803311 (1981). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK803311 LL100 Cryosurgical SystemWallach Surgical Devices, Inc. · 1981 · Recalled
- This deviceK110754 Cryopen Cryosurgical System, K102214Cryopen, Inc. · 2011
- Descendant · cites it directly · 5 of its ownK161480 R2 Dermal Cooling SystemR2 Dermatology · 2016
- Descendant · 2 generations on · 4 of its ownK171398 Dermal Cooling SystemR2 Dermatology,Inc · 2017
- Descendant · 3 generations on · 3 of its ownK201260 Dermal Cooling SystemR2 Technologies, Inc. · 2020
- Descendant · 4 generations on · 2 of its ownK203006 R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. · 2021
- Descendant · 5 generations on · 1 of its ownK213294 Dermal Cooling SystemR2 Technologies, Inc. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161480R2 Dermal Cooling SystemR2 Dermatology · 2016 · cites it directly5descendants
- K171398Dermal Cooling SystemR2 Dermatology,Inc · 2017 · 2 generations on4descendants
- K201260Dermal Cooling SystemR2 Technologies, Inc. · 2020 · 3 generations on3descendants
- K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. · 2021 · 4 generations on2descendants
- K213294Dermal Cooling SystemR2 Technologies, Inc. · 2022 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K803311 | LL100 Cryosurgical System | Wallach Surgical Devices, Inc. | 1981 | 3 |
| 0 (this device) | K110754 | Cryopen Cryosurgical System, K102214 | Cryopen, Inc. | 2011 | — |
| +1 | K161480 | R2 Dermal Cooling System | R2 Dermatology | 2016 | — |
| +2 | K171398 | Dermal Cooling System | R2 Dermatology,Inc | 2017 | — |
| +3 | K201260 | Dermal Cooling System | R2 Technologies, Inc. | 2020 | — |
| +4 | K203006 | R2 Dermabrasion Tip (for Dermal Cooling System) | R2 Technologies, Inc. | 2021 | — |
| +5 | K213294 | Dermal Cooling System | R2 Technologies, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 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? (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 |
|---|---|---|---|
| * | K803311 | LL100 Cryosurgical SystemSummary page 3…E. Substantial Equivalence The CryoPen cryosurgical system is substantially equivalent to the Wallach LLlOO0 Predicate Device, approved on February 4, 198 1, (reference K80331 1) based on the nonclinical bench testing performed on ballistic gelatin. Data generated from bench testing shows the CryoPen is ab… | 1981 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161480 | R2 Dermal Cooling System | 2016 | 5 |
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?
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Cryosurgical unit used for ablative type surgical technique on mfultiple organ systems, wide range of disease, viral, premalignant and malignant tissue.
Cryosurgical instrument used to necrose unwanted tissue in the gynecological and dermatological practice
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/K110754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110754: Cryopen Cryosurgical System, K102214.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110754
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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