510(k) · Cleared
ClearedFocused Cryotherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focused Cryo, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Dec 9, 2025 as substantially equivalent to K201588 (Varian Medical Systems, Inc., 2020) and 1 other predicate after a 273-day review. Its family tree reaches back 12 generations to 1993.
- Decided
- Dec 9, 2025
- Review
- 273 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K926514 (1993). 50 ancestors in all, the oldest K850478 (1985). No later device cites it as a predicate yet.
- Root · 12 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 8 generations between
- 3 generations backK151968 Cryocare CS-3 Surgical System version 5Healthtronics · 2015
- 2 generations backK153489 Cryocare CS Surgical SystemHealthtronics · 2016
- 1 generation backK201588 CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice…Varian Medical Systems, Inc. · 2020
- This deviceK250742 Focused Cryotherapy SystemFocused Cryo, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 11 generations backK963023 Ultrasound Gastroscope GF Type UM30POlympus America, Inc. · 1997
- 10 generations backK994373 Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal…Atl Ultrasound, Inc. · 2000
- 9 generations backK030191 Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp. · 2003
- 8 generations backK032333 Cryocare CS Surgical SystemEndocare, Inc. · 2003
- 7 generations backK050347 Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005
- 6 generations backK060279 Cryocare CS Surgical SystemEndocare, Inc. · 2006 · Recalled
- 5 generations backK101333 Cryocare CS Surgical SystemEndocare, Inc. · 2010 · Recalled
- 4 generations backK141110 Cryocare CS Surgical SystemHealthtronics · 2015
- 3 generations backK151968 Cryocare CS-3 Surgical System version 5Healthtronics · 2015
- 2 generations backK153489 Cryocare CS Surgical SystemHealthtronics · 2016
- 1 generation backK201588 CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice…Varian Medical Systems, Inc. · 2020
- This deviceK250742 Focused Cryotherapy SystemFocused Cryo, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −11 | K963023 | Ultrasound Gastroscope GF Type UM30P | Olympus America, Inc. | 1997 | — |
| −10 | K994373 | Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound… | Atl Ultrasound, Inc. | 2000 | — |
| −9 | K030191 | Terason Model 2000/Bas Portable Ultrasound System | Teratech Corp. | 2003 | — |
| −8 | K032333 | Cryocare CS Surgical System | Endocare, Inc. | 2003 | — |
| −7 | K050347 | Modification to Cryocare CS Surgical System | Endocare, Inc. | 2005 | — |
| −6 | K060279 | Cryocare CS Surgical System | Endocare, Inc. | 2006 | 3 |
| −5 | K101333 | Cryocare CS Surgical System | Endocare, Inc. | 2010 | 2 |
| −4 | K141110 | Cryocare CS Surgical System | Healthtronics | 2015 | — |
| −3 | K151968 | Cryocare CS-3 Surgical System version 5 | Healthtronics | 2015 | — |
| −2 | 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 | — |
| 0 (this device) | K250742 | Focused Cryotherapy System | Focused Cryo, Inc. | 2025 | — |
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 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Summary page 6…ories Regulation Number: 21 CFR 878.4350 Product Code: GEH 3. Predicate Devices: Primary: CRYOCARE TOUCH™ System and Accessories (K201588) Secondary: Visual-ICE Cryoablation System (K230551) 4. Device Description: The Focused Cryotherapy System is a cryoablati… | 2020 |
| * | K230551 | Visual-ICE Cryoablation SystemSummary page 6…Product Code: GEH 3. Predicate Devices: Primary: CRYOCARE TOUCH™ System and Accessories (K201588) Secondary: Visual-ICE Cryoablation System (K230551) 4. Device Description: The Focused Cryotherapy System is a cryoablation platform that contains the following components:… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 8 companies; a new generation was cleared every 3.1 years on median.
- 20 of the 50 ancestors have a recall of any class.
- 3 other devices also cite its predicate K201588.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Focused Cryotherapy System is intended for cryoablative destruction of tissue during surgical procedures. The Focused Cryotherapy System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold…
Read the full statement (279 words)
The Focused Cryotherapy System is intended for cryoablative destruction of tissue during surgical procedures. The Focused Cryotherapy System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), 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, nerves, tumors, and skin lesions.
In addition, the system is intended for use in the following indications:
Urology
* Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH)
Oncology
* Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy
Dermatology
* Ablation or freezing of skin cancers and other cutaneous disorders
* Destruction of warts or lesions, 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, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumors of the skin
Gynecology
* Ablation of malignant neoplasia or benign dysplasia of the female genitalia
General surgery
* Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas
ENT
* Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth
Thoracic Surgery
* (with the exception of cardiac tissue)
Proctology
* Ablation of benign or malignant growths of the anus or rectum
Neurology
* Freezing of nerve tissue in pain management/cryoanalgesia
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250742: Focused Cryotherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250742
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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