510(k) · Cleared
ClearedTrufreeze System, Trufreeze Spray Kit
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 Feb 7, 2012 as substantially equivalent to K040809 (Crymed Technologies, Inc., 2004) and 3 other predicates after a 119-day review. Its family tree reaches back 4 generations to 1984.
- Decided
- Feb 7, 2012
- Review
- 119 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K840536 (1984). 16 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- Root · 4 generations backK840536 Cryo Surg 5900Frigitronics of Connecticut, Inc. · 1984
- 3 generations backK970995 CMS CryoliteCryomedical Sciences, Inc. · 1997
- 2 generations backK040809 Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004
- 1 generation backK060555 Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006
- This deviceK113021 Trufreeze System, Trufreeze Spray KitCSA Medical, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K840536 | Cryo Surg 5900 | Frigitronics of Connecticut, Inc. | 1984 | — |
| −3 | K970995 | CMS Cryolite | Cryomedical Sciences, Inc. | 1997 | — |
| −2 | K040809 | Crymed Cryo-Ablator | Crymed Technologies, Inc. | 2004 | — |
| −1 | K060555 | Spraygenix Cryo Ablation System | Crymed Technologies, Inc. | 2006 | — |
| 0 (this device) | K113021 | Trufreeze System, Trufreeze Spray Kit | CSA Medical, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040809 | Crymed Cryo-AblatorSummary page 1…ulation Number 21 CFR 878.4350 Classification Product Code GEH Predicate Devices CryMed Cryo-Ablator (K040809) CryoSpray Ablation System (K060555, K070265 1)… | 2004 |
| * | K060555 | Spraygenix Cryo Ablation SystemSummary page 1…Code GEH Predicate Devices CryMed Cryo-Ablator (K040809) CryoSpray Ablation System (K060555, K070265 1) Mobile Care Monitor (K090 138)… | 2006 |
| Kept off the family tree | K070265 | FDA’s K070265 is Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus Identification and Typing Kit… Our reading of the summary gave K070265, FDA’s number for Diagnostic Hybrids' D3 Dfa Herpes Simplex Virus… (Diagnostic Hybrids, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “CryoSpray Ablation System”. Kept off the family tree. Summary page 1…GEH Predicate Devices CryMed Cryo-Ablator (K040809) CryoSpray Ablation System (K060555, K070265 1) Mobile Care Monitor (K090 138) Smart W… | 2007 |
| * | K090138 | Mobilecare Monitor, Model 2100Summary page 1…tor (K040809) CryoSpray Ablation System (K060555, K070265 1) Mobile Care Monitor (K090 138) Smart Wand-DIX System (K093557) Device Description The truFreezeg System is a cry… | 2009 |
| * | K093557 | Smartwand-DTXSummary page 1…System (K060555, K070265 1) Mobile Care Monitor (K090 138) Smart Wand-DIX System (K093557) Device Description The truFreezeg System is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation ar… | 2009 |
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 28 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 2 other devices also cite its predicate K040809.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 intended for use as a cryosuirgical tool for the destruction of unwanted tissue in the fields of dermatology, gynecology, and general surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113021: Trufreeze System, Trufreeze Spray Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113021
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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