510(k) · Cleared
ClearedCryoprobe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H&O Equipments, Nv/Sa · GEH Unit, Cryosurgical, Accessories
Cleared on Mar 20, 2003 after a 106-day review. The FDA summary names its predicate without a number. 27 later devices descend from it.
- Decided
- Mar 20, 2003
- Review
- 106 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 5 citing it directly.
- This deviceK024009 CryoprobeH&O Equipments, Nv/Sa · 2003
- Descendant · cites it directly · 11 of its ownK083493 Myoscience Cryo-TouchMyoscience, Inc. · 2009
- Descendant · 2 generations on · 10 of its ownK100447 Myoscience Cryo-TouchMyoscience, Inc. · 2010
- Descendant · 3 generations on · 9 of its ownK102021 Cryo-Touch IIMyoscience, Inc. · 2010
- Descendant · 2 generations on · 8 of its ownK120415 Cryo-Touch IiiMyoscience, Inc. · 2012
- Descendant · cites it directly · 8 of its ownK102006 CryomegaStc Consulting, LLC · 2010
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K083493Myoscience Cryo-TouchMyoscience, Inc. · 2009 · cites it directly11descendants
- K100447Myoscience Cryo-TouchMyoscience, Inc. · 2010 · 2 generations on10descendants
- K102021Cryo-Touch IIMyoscience, Inc. · 2010 · 3 generations on9descendants
- K120415Cryo-Touch IiiMyoscience, Inc. · 2012 · 2 generations on8descendants
- K102006CryomegaStc Consulting, LLC · 2010 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024009 | Cryoprobe | H&O Equipments, Nv/Sa | 2003 | — |
| +1 | K083493 | Myoscience Cryo-Touch | Myoscience, Inc. | 2009 | — |
| +2 | K100447 | Myoscience Cryo-Touch | Myoscience, Inc. | 2010 | — |
| +3 | K102021 | Cryo-Touch II | Myoscience, Inc. | 2010 | — |
| +2 | K120415 | Cryo-Touch Iii | Myoscience, Inc. | 2012 | — |
| +1 | K102006 | Cryomega | Stc Consulting, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | — | Wallach Surgical Ultra Freeze and Cold Soaker Named without a submission number | |
| * | — | Erbokryo CA Cryosurgical System Named without a submission number |
What descends from it? (27)
See all 275 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, K083493 (Myoscience, Inc., 2009) has gone furthest, with 11 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?
To destroy tissue during surgical procedures by applying extreme cold.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024009 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024009: Cryoprobe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024009
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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