510(k) · Cleared
ClearedIce-Sense
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arbel Medical, Ltd. · GEH Unit, Cryosurgical, Accessories
Cleared on Dec 10, 2007 as substantially equivalent to K970995 (Cryomedical Sciences, Inc., 1997) and 3 other predicates after a 62-day review. Its family tree reaches back 2 generations to 1995. 26 later devices descend from it.
- Decided
- Dec 10, 2007
- Review
- 62 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K953637 (1995). 6 ancestors in all, the oldest K840536 (1984). 26 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK953637 CMS Accuprobe 550/530Cryomedical Sciences, Inc. · 1995
- 1 generation backK964336 CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680Cryomedical Sciences, Inc. · 1997
- This deviceK072883 Ice-SenseArbel Medical, Ltd. · 2007
- Descendant · cites it directly · 25 of its ownK102360 Icesence 3IceCure Medical, Ltd. · 2010 · Recalled
- Descendant · 2 generations on · 20 of its ownK133258 Trufreeze SystemCSA Medical, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 19 of its ownK143625 truFreeze SystemCSA Medical, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 11 of its ownK150920 truFreeze SystemCSA Medical, Inc. · 2015
- Descendant · 4 generations on · 10 of its ownK152668 truFreeze SystemCSA Medical, Inc. · 2015
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K102360Icesence 3IceCure Medical, Ltd. · 2010 · cites it directly25descendants
- K133258Trufreeze SystemCSA Medical, Inc. · 2014 · 2 generations on20descendants
- K143625truFreeze SystemCSA Medical, Inc. · 2015 · 3 generations on19descendants
- K150920truFreeze SystemCSA Medical, Inc. · 2015 · 4 generations on11descendants
- K152668truFreeze SystemCSA Medical, Inc. · 2015 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953637 | CMS Accuprobe 550/530 | Cryomedical Sciences, Inc. | 1995 | — |
| −1 | K964336 | CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680 | Cryomedical Sciences, Inc. | 1997 | — |
| 0 (this device) | K072883 | Ice-Sense | Arbel Medical, Ltd. | 2007 | — |
| +1 | K102360 | Icesence 3 | IceCure Medical, Ltd. | 2010 | 1 |
| +2 | K133258 | Trufreeze System | CSA Medical, Inc. | 2014 | 1 |
| +3 | K143625 | truFreeze System | CSA Medical, Inc. | 2015 | 1 |
| +4 | K150920 | truFreeze System | CSA Medical, Inc. | 2015 | — |
| +4 | K152668 | truFreeze System | CSA Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 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? (4)
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 |
|---|---|---|---|
| * | K970995 | CMS CryoliteSummary page 2…ancy (Israel) Ltd. Establishment Registration Number: N/A Owner/operator number: N/A Predicate Devices Cryomedical Sciences Cryolite (K970995), Cryomedical Sciences Accuprobe 610 (K964366, K973190) and Galil Medical Cryo-Hit (K980913) Intended Use / Indications for Use… | 1997 |
| * | K964336 | CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680 Our reading of the summary gave K964366, FDA’s number for Eagle Eyes (Mech-Tronic Precision Mfg., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Cryomedical Sciences Accuprobe 610”. | 1997 |
| * | K973190 | Accuprobe 450, Accuprobe 550/530 and the Accuprobe 600 SeriesSummary page 2…N/A Owner/operator number: N/A Predicate Devices Cryomedical Sciences Cryolite (K970995), Cryomedical Sciences Accuprobe 610 (K964366, K973190) and Galil Medical Cryo-Hit (K980913) Intended Use / Indications for Use The ICE-SENSE Tm device has the following indications… | 1997 |
| * | K980913 | Cryo-Hit Model Numbers EP3T3, EP5T2, EP5T5, EP7T5, EP8T5Summary page 2…N/A Predicate Devices Cryomedical Sciences Cryolite (K970995), Cryomedical Sciences Accuprobe 610 (K964366, K973190) and Galil Medical Cryo-Hit (K980913) Intended Use / Indications for Use The ICE-SENSE Tm device has the following indications for use: Urology · The system ma… | 1998 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102360 | Icesence 3 | 2010 | 25 |
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?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 10.7 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K102360 (IceCure Medical, Ltd., 2010) has gone furthest, with 25 descendants of its own.
- 2 other devices also cite its predicate K970995.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The ICE-SENSE Tm device has the following indications for use: Urology * The system may be used to ablate prostatic tissue. * The system may be used for the ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia Oncology * The system may be used for ablation of cancerous or malignant tissue. * The system may be used for ablation of benign tumors. * The system may be used for palliative intervention. Dermatology · The…
Read the full statement (258 words)
The ICE-SENSE Tm device has the following indications for use:
Urology
* The system may be used to ablate prostatic tissue.
* The system may be used for the ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia
Oncology
* The system may be used for ablation of cancerous or malignant tissue.
* The system may be used for ablation of benign tumors.
* The system may be used for palliative intervention.
Dermatology
· The system may be used for the ablation or freezing of skin cancers and other ctaneous disorders.
Gynecology
*The system may be used for the ablation of malignant neoplasia or benign dysplasia of the female genitalia.
General Surgery
* The system may be used for the ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar wadts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions.
* The system may be used for the destruction of warts or lesions.
* The system may be used for the palliation of tumors of the oral cavity, rectum, and skin.
ThoracicSrgr
* The system may be used for the ablation of arrhythmic cardiac tissue.
* The system may be used for the ablation of cancerous lesions
Proctology
* The system may be used for the ablation of benign or malignant growths of the anus and rectum
* The systems may be used for the ablation of hemorrhoids
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072883: Ice-Sense.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072883
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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