510(k) · Cleared
ClearedCryo Surg 5900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Frigitronics of Connecticut, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Apr 23, 1984 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 38 later devices descend from it.
- Decided
- Apr 23, 1984
- Review
- 75 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 0
38 later devices descend from it, 3 citing it directly.
- This deviceK840536 Cryo Surg 5900Frigitronics of Connecticut, Inc. · 1984
- Descendant · cites it directly · 37 of its ownK970995 CMS CryoliteCryomedical Sciences, Inc. · 1997
- Descendant · 2 generations on · 26 of its ownK072883 Ice-SenseArbel Medical, Ltd. · 2007
- Descendant · 3 generations on · 25 of its ownK102360 Icesence 3IceCure Medical, Ltd. · 2010 · Recalled
- Descendant · 4 generations on · 20 of its ownK133258 Trufreeze SystemCSA Medical, Inc. · 2014 · Recalled
- Descendant · 5 generations on · 19 of its ownK143625 truFreeze SystemCSA Medical, Inc. · 2015 · Recalled
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K970995CMS CryoliteCryomedical Sciences, Inc. · 1997 · cites it directly37descendants
- K072883Ice-SenseArbel Medical, Ltd. · 2007 · 2 generations on26descendants
- K102360Icesence 3IceCure Medical, Ltd. · 2010 · 3 generations on25descendants
- K133258Trufreeze SystemCSA Medical, Inc. · 2014 · 4 generations on20descendants
- K143625truFreeze SystemCSA Medical, Inc. · 2015 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K840536 | Cryo Surg 5900 | Frigitronics of Connecticut, Inc. | 1984 | — |
| +1 | K970995 | CMS Cryolite | Cryomedical Sciences, Inc. | 1997 | — |
| +2 | K072883 | Ice-Sense | Arbel Medical, Ltd. | 2007 | — |
| +3 | K102360 | Icesence 3 | IceCure Medical, Ltd. | 2010 | 1 |
| +4 | K133258 | Trufreeze System | CSA Medical, Inc. | 2014 | 1 |
| +5 | K143625 | truFreeze System | CSA Medical, Inc. | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (38)
See all 383 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, K970995 (Cryomedical Sciences, Inc., 1997) has gone furthest, with 37 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 | — |
https://510kreport.com/device/K840536 · printed Nov 5, 2026
Cite this page
510(k) Report. “K840536: Cryo Surg 5900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K840536
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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