510(k) · Cleared
ClearedtruFreeze System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CSA Medical, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on May 24, 2017 as substantially equivalent to K162695 (CSA Medical, Inc., 2016) after a 187-day review. Its family tree reaches back 15 generations to 2001. 5 later devices descend from it.
- Decided
- May 24, 2017
- Review
- 187 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K003811 (2001). 27 ancestors in all, the oldest K790187 (1979). 5 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK003811 Cryocare Surgical SystemEndocare, Inc. · 2001
- 11 generations between
- 3 generations backK160273 truFreeze SystemCsa Medial, Inc. · 2016
- 2 generations backK161557 truFreeze SystemCSA Medical, Inc. · 2016
- 1 generation backK162695 truFreeze SystemCSA Medical, Inc. · 2016
- This deviceK163244 truFreeze SystemCSA Medical, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK171626 truFreeze SystemCSA Medical, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK222272 truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN…STERIS Corporation · 2022
- Descendant · 3 generations on · 0 of its ownK223369 truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN…STERIS Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK201183 Vortex Radial Spray CatheterCSA Medical, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK172041 truFreeze SystemCSA Medical, Inc. · 2017
Show all 15 generations
- Root · 15 generations backK003811 Cryocare Surgical SystemEndocare, Inc. · 2001
- 14 generations backK020605 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
- 13 generations backK021211 Modification to Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
- 12 generations backK022314 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · Recalled
- 11 generations backK052861 Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005
- 10 generations backK061510 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006
- 9 generations backK062896 V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models…Sanarus Medical, Inc. · 2007
- 8 generations backK102360 Icesence 3IceCure Medical, Ltd. · 2010 · Recalled
- 7 generations backK133258 Trufreeze SystemCSA Medical, Inc. · 2014 · Recalled
- 6 generations backK143625 truFreeze SystemCSA Medical, Inc. · 2015 · Recalled
- 5 generations backK150920 truFreeze SystemCSA Medical, Inc. · 2015
- 4 generations backK152668 truFreeze SystemCSA Medical, Inc. · 2015
- 3 generations backK160273 truFreeze SystemCsa Medial, Inc. · 2016
- 2 generations backK161557 truFreeze SystemCSA Medical, Inc. · 2016
- 1 generation backK162695 truFreeze SystemCSA Medical, Inc. · 2016
- This deviceK163244 truFreeze SystemCSA Medical, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K171626truFreeze SystemCSA Medical, Inc. · 2017 · cites it directly3descendants
- K222272truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation · 2022 · 2 generations on1descendant
- K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation · 2022 · 3 generations on0descendants
- K201183Vortex Radial Spray CatheterCSA Medical, Inc. · 2020 · 2 generations on0descendants
- K172041truFreeze SystemCSA Medical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K003811 | Cryocare Surgical System | Endocare, Inc. | 2001 | — |
| −14 | K020605 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | — |
| −13 | K021211 | Modification to Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | — |
| −12 | K022314 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | 1 |
| −11 | K052861 | Modification to:Sanarus Visica Treatment System , Models VS2000 | Sanarus Medical, Inc. | 2005 | — |
| −10 | K061510 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2006 | — |
| −9 | K062896 | V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000… | Sanarus Medical, Inc. | 2007 | — |
| −8 | K102360 | Icesence 3 | IceCure Medical, Ltd. | 2010 | 1 |
| −7 | K133258 | Trufreeze System | CSA Medical, Inc. | 2014 | 1 |
| −6 | K143625 | truFreeze System | CSA Medical, Inc. | 2015 | 1 |
| −5 | K150920 | truFreeze System | CSA Medical, Inc. | 2015 | — |
| −4 | K152668 | truFreeze System | CSA Medical, Inc. | 2015 | — |
| −3 | K160273 | truFreeze System | Csa Medial, Inc. | 2016 | — |
| −2 | K161557 | truFreeze System | CSA Medical, Inc. | 2016 | — |
| −1 | K162695 | truFreeze System | CSA Medical, Inc. | 2016 | — |
| 0 (this device) | K163244 | truFreeze System | CSA Medical, Inc. | 2017 | — |
| +1 | K171626 | truFreeze System | CSA Medical, Inc. | 2017 | — |
| +2 | K222272 | truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16… | STERIS Corporation | 2022 | — |
| +3 | K223369 | truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16… | STERIS Corporation | 2022 | — |
| +2 | K201183 | Vortex Radial Spray Catheter | CSA Medical, Inc. | 2020 | — |
| +1 | K172041 | truFreeze System | CSA Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K162695 | truFreeze SystemSummary page 4…21 CFR 878.4350 Classification Product Code GEH Predicate Device K162695 (truFreeze® System) Reference Devices K152329 (Coldplay CryoBalloon™ Focal Ablation System),… | 2016 |
| † | K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System | 2016 |
| † | K083737 | Halo Ablation Catheter | 2009 |
| † | K161202 | C2 Cryoballoon Ablation System | 2017 |
What descends from it? (5)
2 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)
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 16 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 4 of the 27 ancestors have a recall of any class.
- Of its descendants, K171626 (CSA Medical, Inc., 2017) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K162695.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (e.g. Barrett’s Esophagus with high grade dysplasia) and malignant lesions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163244: truFreeze System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163244
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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