510(k) · Cleared
ClearedtruFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · GEH Unit, Cryosurgical, Accessories
Cleared on Dec 2, 2022 as substantially equivalent to K222272 (STERIS Corporation, 2022) after a 28-day review. Its family tree reaches back 18 generations to 2001.
- Decided
- Dec 2, 2022
- Review
- 28 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K003811 (2001). 30 ancestors in all, the oldest K790187 (1979). No later device cites it as a predicate yet.
- Root · 18 generations backK003811 Cryocare Surgical SystemEndocare, Inc. · 2001
- 14 generations between
- 3 generations backK163244 truFreeze SystemCSA Medical, Inc. · 2017
- 2 generations backK171626 truFreeze SystemCSA Medical, Inc. · 2017
- 1 generation backK222272 truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN…STERIS Corporation · 2022
- This deviceK223369 truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN…STERIS Corporation · 2022
Show all 18 generations
- Root · 18 generations backK003811 Cryocare Surgical SystemEndocare, Inc. · 2001
- 17 generations backK020605 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
- 16 generations backK021211 Modification to Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
- 15 generations backK022314 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · Recalled
- 14 generations backK052861 Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005
- 13 generations backK061510 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006
- 12 generations backK062896 V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models…Sanarus Medical, Inc. · 2007
- 11 generations backK102360 Icesence 3IceCure Medical, Ltd. · 2010 · Recalled
- 10 generations backK133258 Trufreeze SystemCSA Medical, Inc. · 2014 · Recalled
- 9 generations backK143625 truFreeze SystemCSA Medical, Inc. · 2015 · Recalled
- 8 generations backK150920 truFreeze SystemCSA Medical, Inc. · 2015
- 7 generations backK152668 truFreeze SystemCSA Medical, Inc. · 2015
- 6 generations backK160273 truFreeze SystemCsa Medial, Inc. · 2016
- 5 generations backK161557 truFreeze SystemCSA Medical, Inc. · 2016
- 4 generations backK162695 truFreeze SystemCSA Medical, Inc. · 2016
- 3 generations backK163244 truFreeze SystemCSA Medical, Inc. · 2017
- 2 generations backK171626 truFreeze SystemCSA Medical, Inc. · 2017
- 1 generation backK222272 truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN…STERIS Corporation · 2022
- This deviceK223369 truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN…STERIS Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K003811 | Cryocare Surgical System | Endocare, Inc. | 2001 | — |
| −17 | K020605 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | — |
| −16 | K021211 | Modification to Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | — |
| −15 | K022314 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | 1 |
| −14 | K052861 | Modification to:Sanarus Visica Treatment System , Models VS2000 | Sanarus Medical, Inc. | 2005 | — |
| −13 | K061510 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2006 | — |
| −12 | K062896 | V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000… | Sanarus Medical, Inc. | 2007 | — |
| −11 | K102360 | Icesence 3 | IceCure Medical, Ltd. | 2010 | 1 |
| −10 | K133258 | Trufreeze System | CSA Medical, Inc. | 2014 | 1 |
| −9 | K143625 | truFreeze System | CSA Medical, Inc. | 2015 | 1 |
| −8 | K150920 | truFreeze System | CSA Medical, Inc. | 2015 | — |
| −7 | K152668 | truFreeze System | CSA Medical, Inc. | 2015 | — |
| −6 | K160273 | truFreeze System | Csa Medial, Inc. | 2016 | — |
| −5 | K161557 | truFreeze System | CSA Medical, Inc. | 2016 | — |
| −4 | K162695 | truFreeze System | CSA Medical, Inc. | 2016 | — |
| −3 | K163244 | truFreeze System | CSA Medical, Inc. | 2017 | — |
| −2 | K171626 | truFreeze System | CSA Medical, Inc. | 2017 | — |
| −1 | K222272 | truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16… | STERIS Corporation | 2022 | — |
| 0 (this device) | K223369 | truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16… | STERIS Corporation | 2022 | — |
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 |
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 |
|---|---|---|---|
| * | K222272 | truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…Summary page 5…al Unit Regulation Number: 21 CFR 878.4350 Product Code: GEH 2. Predicate Device truFreeze System, K222272 This submission is for a modification to the device that was the subject of K222272, the predicate device… | 2022 |
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 21 years and passes through 6 companies; a new generation was cleared every 5 months on median.
- 4 of the 30 ancestors have a recall of any class.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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/or low grade dysplasia) and malignant lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223369: truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223369
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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