510(k) · Cleared
Recalled · 2003Sanarus Visica Treatment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanarus Medical, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Oct 15, 2002 as substantially equivalent to K021211 (Sanarus Medical, Inc., 2002) and 1 other predicate after a 90-day review. Its family tree reaches back 3 generations to 2001. 29 later devices descend from it. It has been recalled once.
- Decided
- Oct 15, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003811 (2001). 7 ancestors in all, the oldest K790187 (1979). 29 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK003811 Cryocare Surgical SystemEndocare, Inc. · 2001
- 2 generations backK020605 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
- 1 generation backK021211 Modification to Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
- This deviceK022314 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
- Descendant · cites it directly · 28 of its ownK052861 Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005
- Descendant · cites it directly · 27 of its ownK061510 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006
- Descendant · 2 generations on · 26 of its ownK062896 V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models…Sanarus Medical, Inc. · 2007
- Descendant · 3 generations on · 25 of its ownK102360 Icesence 3IceCure Medical, Ltd. · 2010 · Recalled
- Descendant · 4 generations on · 20 of its ownK133258 Trufreeze SystemCSA Medical, Inc. · 2014 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K052861Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005 · cites it directly28descendants
- K061510Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006 · cites it directly27descendants
- K062896V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600Sanarus Medical, Inc. · 2007 · 2 generations on26descendants
- K102360Icesence 3IceCure Medical, Ltd. · 2010 · 3 generations on25descendants
- K133258Trufreeze SystemCSA Medical, Inc. · 2014 · 4 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003811 | Cryocare Surgical System | Endocare, Inc. | 2001 | — |
| −2 | K020605 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | — |
| −1 | K021211 | Modification to Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | — |
| 0 (this device) | K022314 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | — |
| +1 | K052861 | Modification to:Sanarus Visica Treatment System , Models VS2000 | Sanarus Medical, Inc. | 2005 | — |
| +1 | 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 | — |
| +3 | K102360 | Icesence 3 | IceCure Medical, Ltd. | 2010 | 1 |
| +4 | K133258 | Trufreeze System | CSA Medical, Inc. | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1990 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K021211 | Modification to Sanarus Visica Treatment SystemSummary page 2…ast lesions is substantially equivalent to the Sanarus Visicam Treatment System that was determined to be substantially equivalent on June 26,2002 (reference K0212 11) and the SenoRx Anchor GuideTMLocalization Device that was determined to be substantially equivalent on September 12,… | 2002 |
| * | K012023 | Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator CableSummary page 2…002 (reference K0212 11) and the SenoRx Anchor GuideTMLocalization Device that was determined to be substantially equivalent on September 12, 2001 (reference K012023). (8) Technological Characteristics The VisicaTMTreatment System has comparable technological characteristics and… | 2001 |
What descends from it? (29)
See all 292 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 16, 2003 | Not classified | Z-1008-03 | Other | Corrosion in stainless steel device shaft that allows Argon gas to escape from device during a cryoablation procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 4 months on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K052861 (Sanarus Medical, Inc., 2005) has gone furthest, with 28 descendants of its own.
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 Sanarus Visica Treatment System is intended for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition, the system is intended for use in the following indications:
General Surgery
Ablation of breast fibroadenoma
Localization of breast lesions
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022314: Sanarus Visica Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022314
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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