510(k) Report

510(k) · Cleared

Cleared

Modification to Sanarus Visica Treatment System

K021211510(k) SpecialCleared Jun 26, 200270-day reviewClass II21 CFR 878.4350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sanarus Medical, Inc. · GEH Unit, Cryosurgical, Accessories

Cleared on Jun 26, 2002 as substantially equivalent to K020605 (Sanarus Medical, Inc., 2002) after a 70-day review. Its family tree reaches back 2 generations to 2001. 30 later devices descend from it.

Decided
Jun 26, 2002
Review
70 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K003811 (2001). 30 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2006: 1 descendant cleared2005: 1 descendant cleared2007: 1 descendant cleared2010: 1 descendant cleared2014: 1 descendant cleared2019: 2 descendants cleared2015: 3 descendants cleared2024: 2 descendants cleared2016: 4 descendants cleared2026: 1 descendant cleared2025: 1 descendant cleared2017: 5 descendants cleared2018: 1 descendant cleared2020: 2 descendants cleared2021: 1 descendant cleared2022: 2 descendants clearedK003811 · Cryocare Surgical System · Endocare, Inc. · 2001K020605 · Sanarus Visica Treatment System · Sanarus Medical, Inc. · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 5 descendants8 generations forward: 3 descendants9 generations forward: 2 descendants10 generations forward: 2 descendants11 generations forward: 3 descendants12 generations forward: 3 descendants13 generations forward: 2 descendants14 generations forward: 1 descendant K020605 · Sanarus Visica Treatment System · Sanarus Medical, Inc. · 2002K003811 · Cryocare Surgical System · Endocare, Inc. · 20010+5+10
  1. Root · 2 generations backK003811 Cryocare Surgical SystemEndocare, Inc. · 2001
  2. 1 generation backK020605 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
  3. This deviceK021211 Modification to Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
  4. Descendant · cites it directly · 29 of its ownK022314 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · Recalled
  5. Descendant · 2 generations on · 28 of its ownK052861 Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005
  6. Descendant · 2 generations on · 27 of its ownK061510 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006
  7. Descendant · 3 generations on · 26 of its ownK062896 V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models…Sanarus Medical, Inc. · 2007
  8. Descendant · 4 generations on · 25 of its ownK102360 Icesence 3IceCure Medical, Ltd. · 2010 · Recalled

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2002: 12005: 12006: 12007: 12010: 12014: 12015: 32016: 42017: 52018: 12019: 22020: 22021: 12022: 22024: 22025: 12026: 1
2002high 5 (2017) · low 0 (2003)2026

Most influential descendants

Showing 5 of 30 · See all
  • K022314Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · cites it directly29descendants
  • K052861Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005 · 2 generations on28descendants
  • K061510Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006 · 2 generations on27descendants
  • K062896V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600Sanarus Medical, Inc. · 2007 · 3 generations on26descendants
  • K102360Icesence 3IceCure Medical, Ltd. · 2010 · 4 generations on25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K003811Cryocare Surgical SystemEndocare, Inc.2001—
−1K020605Sanarus Visica Treatment SystemSanarus Medical, Inc.2002—
0 (this device)K021211Modification to Sanarus Visica Treatment SystemSanarus Medical, Inc.2002—
+1K022314Sanarus Visica Treatment SystemSanarus Medical, Inc.20021
+2K052861Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc.2005—
+2K061510Sanarus Visica Treatment SystemSanarus Medical, Inc.2006—
+3K062896V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000…Sanarus Medical, Inc.2007—
+4K102360Icesence 3IceCure Medical, Ltd.20101

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200510
200610
200710
201010
201410
201530
201640
201750
201810
201920
202020
202110
202220
202420
202510
202610
FIG. 1 — Lineage of K021211, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

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  2. #2 Held for the reportin the report
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K020605Sanarus Visica Treatment System
Summary page 2
…ent System is substantially equivalent to the Sanarus VisicaTMTreatment System that was determined to .be substantially equivalent on March 8,2002 (reference K020605). (8) Technological Characteristics The VisicaTMTreatment System has the same technological characteristics and p…
Sanarus Medical, Inc.2002—

What descends from it? (30)

See all 30

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022314Sanarus Visica Treatment SystemSanarus Medical, Inc.200229

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 1 year and passes through 2 companies; a new generation was cleared every 5 months on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K022314 (Sanarus Medical, Inc., 2002) has gone furthest, with 29 descendants of its own.

How does its category compare?

All GEH devices

GEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEH

10in 2025

2007: 62008: 12009: 42010: 42011: 72012: 42013: 42014: 62015: 112016: 152017: 122018: 62019: 62020: 82021: 62022: 62023: 82024: 92025: 102026 (partial year): 8
2007high 15 (2016) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEH

77in 2025

2007: 71 days median2009: 121 days median2010: 86 days median2011: 91 days median2012: 96 days median2013: 76 days median2014: 42 days median2015: 72 days median2016: 60 days median2017: 83 days median2018: 42 days median2019: 115 days median2020: 113 days median2021: 206 days median2022: 56 days median2023: 136 days median2024: 85 days median2025: 77 days median2026 (partial year): 148 days median
2007high 206 (2021) · low 42 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEH

2in 2023

2007: 32008: 22009: 132010: 42012: 32014: 22018: 12019: 12020: 372023: 22026 (partial year): 2
2007high 37 (2020) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEH

171in 2025

2007: 232008: 292009: 212010: 1732011: 612012: 912013: 912014: 572015: 972016: 1432017: 2162018: 2082019: 4552020: 2772021: 2132022: 2302023: 1642024: 1412025: 171
2007high 455 (2019) · low 21 (2009)2025

MAUDE reports naming product code GEH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007671323
20081—229
200941211321
20104864173
2011791061
2012496391
2013476091
2014642257
20151172097
201615600143
201712830216
20186421208
201961151455
2020811337277
202162060213
20226560230
202381362164
20249850141
202510770171
202681482—

What is it indicated for?

The VisicaTMTreatment 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

Gynecology

Ablation of malignant neoplasia or benign dysplasia of the female genitaIia

Oncology

Ablation of cancerous or malignant tissue

Ablation of benign tumors

Palliative intervention

Indications for use as stated in the FDA summary.

More from Sanarus Medical, Inc.

14 FDA decisions under this applicant name. See the company

  • K080171Sanarus Incore Rotational Core Biopsy Device, Models CB3010, CB3012Sanarus Medical, Inc. · 2008
  • K073533Sanarus V2 Treatment SystemSanarus Medical, Inc. · 2008
  • K062896V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600Sanarus Medical, Inc. · 2007
  • K061510Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006
  • K052861Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005

Recent decisions in GEH

The GEH category page

  • K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical · 2026
  • K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical · 2026
  • K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH · 2026
  • K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH · 2026
  • K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V. · 2026

https://510kreport.com/device/K021211 · printed Nov 5, 2026

Cite this page

510(k) Report. “K021211: Modification to Sanarus Visica Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021211

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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