510(k) · Cleared
ClearedCryocare CS Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthtronics · GEH Unit, Cryosurgical, Accessories
Cleared on Feb 5, 2016 as substantially equivalent to K003811 (Endocare, Inc., 2001) and 5 other predicates after a 63-day review. Its family tree reaches back 10 generations to 1993. 5 later devices descend from it.
- Decided
- Feb 5, 2016
- Review
- 63 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 10 generations to K926514 (1993). 46 ancestors in all, the oldest K850478 (1985). 5 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 6 generations between
- 3 generations backK101333 Cryocare CS Surgical SystemEndocare, Inc. · 2010 · Recalled
- 2 generations backK141110 Cryocare CS Surgical SystemHealthtronics · 2015
- 1 generation backK151968 Cryocare CS-3 Surgical System version 5Healthtronics · 2015
- This deviceK153489 Cryocare CS Surgical SystemHealthtronics · 2016
- Descendant · cites it directly · 4 of its ownK201588 CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice…Varian Medical Systems, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK230271 ISOLIS CryoprobeVarian Medical Systems, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK250742 Focused Cryotherapy SystemFocused Cryo, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243042 Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK231661 CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd. · 2023
Show all 10 generations
- Root · 10 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 9 generations backK963023 Ultrasound Gastroscope GF Type UM30POlympus America, Inc. · 1997
- 8 generations backK994373 Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal…Atl Ultrasound, Inc. · 2000
- 7 generations backK030191 Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp. · 2003
- 6 generations backK032333 Cryocare CS Surgical SystemEndocare, Inc. · 2003
- 5 generations backK050347 Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005
- 4 generations backK060279 Cryocare CS Surgical SystemEndocare, Inc. · 2006 · Recalled
- 3 generations backK101333 Cryocare CS Surgical SystemEndocare, Inc. · 2010 · Recalled
- 2 generations backK141110 Cryocare CS Surgical SystemHealthtronics · 2015
- 1 generation backK151968 Cryocare CS-3 Surgical System version 5Healthtronics · 2015
- This deviceK153489 Cryocare CS Surgical SystemHealthtronics · 2016
Most influential descendants
Showing 5 of 5 · See all- K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc. · 2020 · cites it directly4descendants
- K230271ISOLIS CryoprobeVarian Medical Systems, Inc. · 2023 · 2 generations on1descendant
- K250742Focused Cryotherapy SystemFocused Cryo, Inc. · 2025 · 2 generations on0descendants
- K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K231661CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −9 | K963023 | Ultrasound Gastroscope GF Type UM30P | Olympus America, Inc. | 1997 | — |
| −8 | K994373 | Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound… | Atl Ultrasound, Inc. | 2000 | — |
| −7 | K030191 | Terason Model 2000/Bas Portable Ultrasound System | Teratech Corp. | 2003 | — |
| −6 | K032333 | Cryocare CS Surgical System | Endocare, Inc. | 2003 | — |
| −5 | K050347 | Modification to Cryocare CS Surgical System | Endocare, Inc. | 2005 | — |
| −4 | K060279 | Cryocare CS Surgical System | Endocare, Inc. | 2006 | 3 |
| −3 | K101333 | Cryocare CS Surgical System | Endocare, Inc. | 2010 | 2 |
| −2 | K141110 | Cryocare CS Surgical System | Healthtronics | 2015 | — |
| −1 | K151968 | Cryocare CS-3 Surgical System version 5 | Healthtronics | 2015 | — |
| 0 (this device) | K153489 | Cryocare CS Surgical System | Healthtronics | 2016 | — |
| +1 | K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo… | Varian Medical Systems, Inc. | 2020 | — |
| +2 | K230271 | ISOLIS Cryoprobe | Varian Medical Systems, Inc. | 2023 | — |
| +2 | K250742 | Focused Cryotherapy System | Focused Cryo, Inc. | 2025 | — |
| +2 | K243042 | Co-Ablation System with Sterile Co-Ablation Probe | Hygea Medical Technology Co., Ltd. | 2025 | — |
| +2 | K231661 | CryoThin™ Surgical System and Accessories | Medinux (Tianjin) Technologies Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K003811 | Cryocare Surgical SystemSummary page 5…II PRODUCT CODE: GEH REGULATION NUMBER: 21 CFR 878.4350 PREDICATE DEVICE: Cryocare Surgical System K003811 Cleared 10/11/2001 Cryocare CS Surgical System K141110 Cleared 06/25/2015 Cryocare CS Surgical Sys… | 2001 |
| * | K141110 | Cryocare CS Surgical SystemSummary page 5…21 CFR 878.4350 PREDICATE DEVICE: Cryocare Surgical System K003811 Cleared 10/11/2001 Cryocare CS Surgical System K141110 Cleared 06/25/2015 Cryocare CS Surgical System K151968 Cleared 09/09/2015 Galil Medical Visual ICE… | 2015 |
| * | K151968 | Cryocare CS-3 Surgical System version 5Summary page 5…K003811 Cleared 10/11/2001 Cryocare CS Surgical System K141110 Cleared 06/25/2015 Cryocare CS Surgical System K151968 Cleared 09/09/2015 Galil Medical Visual ICE K143564 Cleared 03/05/2015 Galil Medical IceEDGE… | 2015 |
| * | K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1Summary page 5…em K141110 Cleared 06/25/2015 Cryocare CS Surgical System K151968 Cleared 09/09/2015 Galil Medical Visual ICE K143564 Cleared 03/05/2015 Galil Medical IceEDGE K111859 Cleared 10/07/2011 Galil Medical IceRod… | 2015 |
| * | K111859 | Iceedge 2.4 Cryoablation Needle,Iceedge 2.4 Cryoablation Needle MultipackSummary page 5…em K151968 Cleared 09/09/2015 Galil Medical Visual ICE K143564 Cleared 03/05/2015 Galil Medical IceEDGE K111859 Cleared 10/07/2011 Galil Medical IceRod K140584 Cleared 03/31/2014 PRODUCT DESCRIPTION: The E… | 2011 |
| * | K140584 | Icerod CX Cryoablation NeedleSummary page 5…K143564 Cleared 03/05/2015 Galil Medical IceEDGE K111859 Cleared 10/07/2011 Galil Medical IceRod K140584 Cleared 03/31/2014 PRODUCT DESCRIPTION: The Endocare™ Cryocare CS® Surgical System is a mobile console system intended for… | 2014 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe… | 2020 | 4 |
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 23 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 19 of the 46 ancestors have a recall of any class.
- Of its descendants, K201588 (Varian Medical Systems, Inc., 2020) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K003811.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition…
Read the full statement (241 words)
The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
In addition, the system is intended for use in the following indications:
General Surgery
• Destruction of warts or lesions
• Palliation of tumors of the oral cavity, rectum and skin
• Ablation of breast fibroadenomas
• Ablation of leukoplakia of the 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
Urology
• Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia
• Gynecology
• Ablation of malignant neoplasia or benign dysplasia of the female genitalia
Oncology
• Ablation of cancerous or malignant tissue
• Ablation of benign tumors
• Palliative intervention
Neurology
• Freezing of nerve tissue in pain management/cryoanalgesia
Dermatology
• Ablation or freezing of skin cancers and other cutaneous disorders
Proctology
• Ablation of benign or malignant growths of the anus or rectum
• Ablation of hemorrhoids
Thoracic Surgery
• Ablation of arrhythmic cardiac tissue
• Ablation of cancerous lesions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153489 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153489: Cryocare CS Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153489
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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