510(k) · Cleared
ClearedCryocare CN2 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endocare, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Aug 28, 2006 as substantially equivalent to K982055 (Cryomedical Sciences, Inc., 1998) and 2 other predicates after a 28-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Aug 28, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K953637 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK953637 CMS Accuprobe 550/530Cryomedical Sciences, Inc. · 1995
- 2 generations backK964336 CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680Cryomedical Sciences, Inc. · 1997
- 1 generation backK982055 Accuprobe 800 Series Model Numbers : 810, 820, 830, 840, 850, 860…Cryomedical Sciences, Inc. · 1998
- This deviceK062175 Cryocare CN2 SystemEndocare, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953637 | CMS Accuprobe 550/530 | Cryomedical Sciences, Inc. | 1995 | — |
| −2 | K964336 | CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680 | Cryomedical Sciences, Inc. | 1997 | — |
| −1 | K982055 | Accuprobe 800 Series Model Numbers : 810, 820, 830, 840, 850, 860, 870 and 880 | Cryomedical Sciences, Inc. | 1998 | — |
| 0 (this device) | K062175 | Cryocare CN2 System | Endocare, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K982055 | Accuprobe 800 Series Model Numbers : 810, 820, 830, 840, 850, 860, 870 and 880Summary page 1…Devices: Manufacturer Device Name 510-K Number Decision Date Cryomedical Sciences, Inc. CMS Accuprobe® K0982055 Sept. 08, 1998 Cryomedical Sciences, Inc. CMS Accuprobe® K0973190 Nov. 21, 1997… | 1998 |
| * | K973190 | Accuprobe 450, Accuprobe 550/530 and the Accuprobe 600 SeriesSummary page 1…on Date Cryomedical Sciences, Inc. CMS Accuprobe® K0982055 Sept. 08, 1998 Cryomedical Sciences, Inc. CMS Accuprobe® K0973190 Nov. 21, 1997 Cryomedical Sciences, Inc. CMS Accuprobe® K0964336 Mar. 20, 1997 * D… | 1997 |
| * | K964336 | CMS Accuprobe 610, 620, 630, 640, 650, 660, 670, 680Summary page 1…08, 1998 Cryomedical Sciences, Inc. CMS Accuprobe® K0973190 Nov. 21, 1997 Cryomedical Sciences, Inc. CMS Accuprobe® K0964336 Mar. 20, 1997 * Device Description: The Cryocare CN2 System consists of a compact, easy-to-operate console that del… | 1997 |
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 11 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 4 ancestors has a recall.
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 Cryocare CN2 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…
Read the full statement (228 words)
The Cryocare CN2 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 leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, 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/K062175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062175: Cryocare CN2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062175
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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