510(k) · Cleared
ClearedIceSense 3, ProSense, MultiSense
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
IceCure Medical, Ltd. · GEH Unit, Cryosurgical, Accessories
Cleared on Dec 20, 2019 as substantially equivalent to K102360 (IceCure Medical, Ltd., 2010) and 1 other predicate after a 396-day review. Its family tree reaches back 8 generations to 2001. 3 later devices descend from it.
- Decided
- Dec 20, 2019
- Review
- 396 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K003811 (2001). 20 ancestors in all, the oldest K790187 (1979). 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK003811 Cryocare Surgical SystemEndocare, Inc. · 2001
- 7 generations backK020605 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
- 6 generations backK021211 Modification to Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
- 5 generations backK022314 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · Recalled
- 4 generations backK052861 Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005
- 3 generations backK061510 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006
- 2 generations backK062896 V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models…Sanarus Medical, Inc. · 2007
- 1 generation backK102360 Icesence 3IceCure Medical, Ltd. · 2010 · Recalled
- This deviceK183213 IceSense 3, ProSense, MultiSenseIceCure Medical, Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK240892 XSense Cryoablation System with CryoprobesIceCure Medical, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK260377 XSense Cryoablation System with CryoProbesIceCure Medical, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK243042 Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K240892XSense Cryoablation System with CryoprobesIceCure Medical, Ltd. · 2024 · cites it directly2descendants
- K260377XSense Cryoablation System with CryoProbesIceCure Medical, Ltd. · 2026 · 2 generations on0descendants
- K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003811 | Cryocare Surgical System | Endocare, Inc. | 2001 | — |
| −7 | K020605 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | — |
| −6 | K021211 | Modification to Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | — |
| −5 | K022314 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | 1 |
| −4 | K052861 | Modification to:Sanarus Visica Treatment System , Models VS2000 | Sanarus Medical, Inc. | 2005 | — |
| −3 | K061510 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2006 | — |
| −2 | K062896 | V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000… | Sanarus Medical, Inc. | 2007 | — |
| −1 | K102360 | Icesence 3 | IceCure Medical, Ltd. | 2010 | 1 |
| 0 (this device) | K183213 | IceSense 3, ProSense, MultiSense | IceCure Medical, Ltd. | 2019 | — |
| +1 | K240892 | XSense Cryoablation System with Cryoprobes | IceCure Medical, Ltd. | 2024 | — |
| +2 | K260377 | XSense Cryoablation System with CryoProbes | IceCure Medical, Ltd. | 2026 | — |
| +2 | K243042 | Co-Ablation System with Sterile Co-Ablation Probe | Hygea Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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? (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 |
|---|---|---|---|
| * | K102360 | Icesence 3Summary page 5…Page 2 of 9 Predicate Devices The IceCure Family of Cryotherapy Systems is substantially equivalent to the cleared IceSense3 System (K102360) and the cleared Galil Medical Seednet family (K052530). Intended Use / Indications for Use The IceCure Family (IceSense™3, Pro… | 2010 |
| * | K052530 | Seednet, Seednet Gold, Cryohit, CryotheraSummary page 5…e Devices The IceCure Family of Cryotherapy Systems is substantially equivalent to the cleared IceSense3 System (K102360) and the cleared Galil Medical Seednet family (K052530). Intended Use / Indications for Use The IceCure Family (IceSense™3, ProSense™, and MultiSense™) cryoablation system is intende… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240892 | XSense Cryoablation System with Cryoprobes | 2024 | 2 |
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 18 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K240892 (IceCure Medical, Ltd., 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K102360.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 IceCure Family (IceSense™3, ProSense™, and MultiSense™) cryoablation system is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the…
Read the full statement (295 words)
The IceCure Family (IceSense™3, ProSense™, and MultiSense™) cryoablation system is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures.
It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The system has the following specific indications:
Urology (ablate prostate tissue in cases of prostate cancer and benign prostatic hyperplasia (BPH)).
Oncology (ablation of cancerous or malignant tissue and benign tumors and palliative intervention).
Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Palliation of tumors of the skin. Destruction of warts or lesions).
Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia).
ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth).
General Surgery (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 warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. Palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions. Destruction of warts or lesions. Palliation of tumors of the oral cavity, rectum, and skin. Ablation of breast fibroadenomas).
Thoracic Surgery (ablation of arrhythmic cardiac tissue and cancerous lesions).
Proctology (ablation of benign or malignant growths of the anus and rectum and hemorrhoids).
The system may be used with imaging device like ultrasound to provide real-time visualization of the cryosurgical procedure.
MultiSense™ System is indicated for three probe configuration only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183213: IceSense 3, ProSense, MultiSense.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183213
Report an extraction error
Are you the manufacturer?
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