510(k) Report

510(k) · Cleared

Cleared

truFreeze System

K162695510(k) SpecialCleared Oct 25, 201628-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

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

Cleared on Oct 25, 2016 as substantially equivalent to K161557 (CSA Medical, Inc., 2016) after a 28-day review. Its family tree reaches back 14 generations to 2001. 7 later devices descend from it.

Decided
Oct 25, 2016
Review
28 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
1

Its longest line of descent runs back 14 generations to K003811 (2001). 26 ancestors in all, the oldest K790187 (1979). 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2005: 1 other ancestor1998: 1 other ancestor1997: 4 other ancestors1995: 1 other ancestor1984: 1 other ancestor2001: 1 other ancestor1990: 1 other ancestor1979: 1 other ancestor2017: 4 descendants cleared2022: 2 descendants cleared2020: 1 descendant cleared×4: 4 generations cleared close together, K003811 (2001), K020605 (2002), K021211 (2002), K022314 (2002) K052861 · Modification to:Sanarus Visica Treatment System , Models VS2000 · Sanarus Medical, Inc. · 2005×2: 2 generations cleared close together, K061510 (2006), K062896 (2007) K102360 · Icesence 3 · IceCure Medical, Ltd. · 2010 · recalledK133258 · Trufreeze System · CSA Medical, Inc. · 2014 · recalled×5: 5 generations cleared close together, K143625 (2015), K150920 (2015), K152668 (2015), K160273 (2016), K161557 (2016) 19801990200020102020
Other ancestors, by generationDescendants, by generation 7 generations back: 2 other ancestors8 generations back: 4 other ancestors9 generations back: 2 other ancestors10 generations back: 1 other ancestor11 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K161557 · truFreeze System · CSA Medical, Inc. · 2016K160273 · truFreeze System · Csa Medial, Inc. · 2016K152668 · truFreeze System · CSA Medical, Inc. · 2015K150920 · truFreeze System · CSA Medical, Inc. · 2015K143625 · truFreeze System · CSA Medical, Inc. · 2015 · recalledK133258 · Trufreeze System · CSA Medical, Inc. · 2014 · recalledK102360 · Icesence 3 · IceCure Medical, Ltd. · 2010 · recalledK062896 · V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600 · Sanarus Medical, Inc. · 2007K061510 · Sanarus Visica Treatment System · Sanarus Medical, Inc. · 2006K052861 · Modification to:Sanarus Visica Treatment System , Models VS2000 · Sanarus Medical, Inc. · 2005K022314 · Sanarus Visica Treatment System · Sanarus Medical, Inc. · 2002 · recalledK021211 · Modification to Sanarus Visica Treatment System · Sanarus Medical, Inc. · 2002K020605 · Sanarus Visica Treatment System · Sanarus Medical, Inc. · 2002K003811 · Cryocare Surgical System · Endocare, Inc. · 2001−10−50
  1. Root · 14 generations backK003811 Cryocare Surgical SystemEndocare, Inc. · 2001
  2. 10 generations between
  3. 3 generations backK152668 truFreeze SystemCSA Medical, Inc. · 2015
  4. 2 generations backK160273 truFreeze SystemCsa Medial, Inc. · 2016
  5. 1 generation backK161557 truFreeze SystemCSA Medical, Inc. · 2016
  6. This deviceK162695 truFreeze SystemCSA Medical, Inc. · 2016
  7. Descendant · cites it directly · 5 of its ownK163244 truFreeze SystemCSA Medical, Inc. · 2017
  8. Descendant · 2 generations on · 3 of its ownK171626 truFreeze SystemCSA Medical, Inc. · 2017
  9. Descendant · 3 generations on · 1 of its ownK222272 truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN…STERIS Corporation · 2022
  10. Descendant · 4 generations on · 0 of its ownK223369 truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN…STERIS Corporation · 2022
  11. Descendant · 3 generations on · 0 of its ownK201183 Vortex Radial Spray CatheterCSA Medical, Inc. · 2020
Show all 14 generations
  1. Root · 14 generations backK003811 Cryocare Surgical SystemEndocare, Inc. · 2001
  2. 13 generations backK020605 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
  3. 12 generations backK021211 Modification to Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
  4. 11 generations backK022314 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · Recalled
  5. 10 generations backK052861 Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005
  6. 9 generations backK061510 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006
  7. 8 generations backK062896 V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models…Sanarus Medical, Inc. · 2007
  8. 7 generations backK102360 Icesence 3IceCure Medical, Ltd. · 2010 · Recalled
  9. 6 generations backK133258 Trufreeze SystemCSA Medical, Inc. · 2014 · Recalled
  10. 5 generations backK143625 truFreeze SystemCSA Medical, Inc. · 2015 · Recalled
  11. 4 generations backK150920 truFreeze SystemCSA Medical, Inc. · 2015
  12. 3 generations backK152668 truFreeze SystemCSA Medical, Inc. · 2015
  13. 2 generations backK160273 truFreeze SystemCsa Medial, Inc. · 2016
  14. 1 generation backK161557 truFreeze SystemCSA Medical, Inc. · 2016
  15. This deviceK162695 truFreeze SystemCSA Medical, Inc. · 2016

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2017: 42020: 12022: 2
2017high 4 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 7 · See all
  • K163244truFreeze SystemCSA Medical, Inc. · 2017 · cites it directly5descendants
  • K171626truFreeze SystemCSA Medical, Inc. · 2017 · 2 generations on3descendants
  • K222272truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation · 2022 · 3 generations on1descendant
  • K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation · 2022 · 4 generations on0descendants
  • K201183Vortex Radial Spray CatheterCSA Medical, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K003811Cryocare Surgical SystemEndocare, Inc.2001—
−13K020605Sanarus Visica Treatment SystemSanarus Medical, Inc.2002—
−12K021211Modification to Sanarus Visica Treatment SystemSanarus Medical, Inc.2002—
−11K022314Sanarus Visica Treatment SystemSanarus Medical, Inc.20021
−10K052861Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc.2005—
−9K061510Sanarus Visica Treatment SystemSanarus Medical, Inc.2006—
−8K062896V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000…Sanarus Medical, Inc.2007—
−7K102360Icesence 3IceCure Medical, Ltd.20101
−6K133258Trufreeze SystemCSA Medical, Inc.20141
−5K143625truFreeze SystemCSA Medical, Inc.20151
−4K150920truFreeze SystemCSA Medical, Inc.2015—
−3K152668truFreeze SystemCSA Medical, Inc.2015—
−2K160273truFreeze SystemCsa Medial, Inc.2016—
−1K161557truFreeze SystemCSA Medical, Inc.2016—
0 (this device)K162695truFreeze SystemCSA Medical, Inc.2016—
+1K163244truFreeze SystemCSA Medical, Inc.2017—
+2K171626truFreeze SystemCSA Medical, Inc.2017—
+3K222272truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16…STERIS Corporation2022—
+4K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16…STERIS Corporation2022—
+3K201183Vortex Radial Spray CatheterCSA Medical, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198410
199010
199510
199740
199810
200110
200510
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201740
202010
202220
FIG. 1 — Lineage of K162695, 2001–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

  1. #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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
*K161557truFreeze System
Summary page 4
…21 CFR 878.4350 Classification Product Code GEH Predicate Device K161557 (truFreeze System) Device Description The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to…
CSA Medical, Inc.2016—

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K163244truFreeze SystemCSA Medical, Inc.20175
K171522truFreeze Rapid AV Spray KitCSA Medical, Inc.20170

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 15 years and passes through 5 companies; a new generation was cleared every 5 months on median.
  • 4 of the 26 ancestors have a recall of any class.
  • Of its descendants, K163244 (CSA Medical, Inc., 2017) has gone furthest, with 5 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. 2016, this device’s year, is highlighted.

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 truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -

1960C requiring either active or passive venting during surgical procedures.

The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.

Indications for use as stated in the FDA summary.

More from CSA Medical, Inc.

14 FDA decisions under this applicant name. See the company

  • K201183Vortex Radial Spray CatheterCSA Medical, Inc. · 2020
  • K171626truFreeze SystemCSA Medical, Inc. · 2017
  • K172041truFreeze SystemCSA Medical, Inc. · 2017
  • K171522truFreeze Rapid AV Spray KitCSA Medical, Inc. · 2017
  • K163244truFreeze SystemCSA Medical, Inc. · 2017

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/K162695 · printed Nov 5, 2026

Cite this page

510(k) Report. “K162695: truFreeze System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162695

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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