510(k) · Cleared
ClearedCMS Cryolite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cryomedical Sciences, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Jul 7, 1997 as substantially equivalent to K840536 (Frigitronics of Connecticut, Inc., 1984) after a 110-day review. Its family tree reaches back 1 generation to 1984. 37 later devices descend from it.
- Decided
- Jul 7, 1997
- Review
- 110 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K840536 (1984). 37 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK840536 Cryo Surg 5900Frigitronics of Connecticut, Inc. · 1984
- This deviceK970995 CMS CryoliteCryomedical Sciences, Inc. · 1997
- Descendant · cites it directly · 26 of its ownK072883 Ice-SenseArbel Medical, Ltd. · 2007
- Descendant · 2 generations on · 25 of its ownK102360 Icesence 3IceCure Medical, Ltd. · 2010 · Recalled
- Descendant · 3 generations on · 20 of its ownK133258 Trufreeze SystemCSA Medical, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 19 of its ownK143625 truFreeze SystemCSA Medical, Inc. · 2015 · Recalled
- Descendant · cites it directly · 16 of its ownK040809 Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K072883Ice-SenseArbel Medical, Ltd. · 2007 · cites it directly26descendants
- K102360Icesence 3IceCure Medical, Ltd. · 2010 · 2 generations on25descendants
- K133258Trufreeze SystemCSA Medical, Inc. · 2014 · 3 generations on20descendants
- K143625truFreeze SystemCSA Medical, Inc. · 2015 · 4 generations on19descendants
- K040809Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004 · cites it directly16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K840536 | Cryo Surg 5900 | Frigitronics of Connecticut, Inc. | 1984 | — |
| 0 (this device) | K970995 | CMS Cryolite | Cryomedical Sciences, Inc. | 1997 | — |
| +1 | K072883 | Ice-Sense | Arbel Medical, Ltd. | 2007 | — |
| +2 | K102360 | Icesence 3 | IceCure Medical, Ltd. | 2010 | 1 |
| +3 | K133258 | Trufreeze System | CSA Medical, Inc. | 2014 | 1 |
| +4 | K143625 | truFreeze System | CSA Medical, Inc. | 2015 | 1 |
| +1 | K040809 | Crymed Cryo-Ablator | Crymed Technologies, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (3)
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 |
|---|---|---|---|
| * | K840536 | Cryo Surg 5900Summary page 1…ve to typical resection in certain cases. The CMS Cryo-lite® System is similar in form and function to the Frigitronics' Cryocare | System and its Cryo Surg Model 5900 (K840536) and Cabot Medical's Cryomedics MT700. Intended use for the CMS Cryo-lite® System is the same as those listed for the CMS Cryolit… | 1984 |
| * | — | Frigitronics Cryocare I Named without a submission number | |
| * | — | Cryomedics Model MT700 Named without a submission number |
What descends from it? (37)
See all 373 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?
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 CMS Cryo-lite® System has the same indications for use as its predicate devices, the Frigitronics Model 5900, Frigitronics Cryocare I and the Cryomedics Model MT700. The Cryo-lite® System is intended to be used as a cryosurgical tool for destruction of unwanted tissug itr the fields of dermatology, ‘gynecology general surgery, etc. and veterinary medicine.
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/K970995 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970995: CMS Cryolite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970995
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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