510(k) · Cleared
ClearedCoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medinice S.A. · GEH Unit, Cryosurgical, Accessories
Cleared on Feb 13, 2026 as substantially equivalent to K152337 (AtriCure, Inc., 2016) after a 235-day review. Its family tree reaches back 15 generations to 1995.
- Decided
- Feb 13, 2026
- Review
- 235 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K942299 (1995). 55 ancestors in all, the oldest K781302 (1978). No later device cites it as a predicate yet.
- Root · 15 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 11 generations between
- 3 generations backK140058 Atricure Cryo Module SystemAtriCure, Inc. · 2014 · Recalled
- 2 generations backK142203 Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014
- 1 generation backK152337 cryoFORM cryoICE cryoablation probeAtriCure, Inc. · 2016
- This deviceK251928 CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01)…Medinice S.A. · 2026
Show all 15 generations
- Root · 15 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 14 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 13 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 12 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 11 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 10 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 9 generations backK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- 8 generations backK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
- 7 generations backK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · Recalled
- 6 generations backK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
- 5 generations backK112072 Atricure Cryo Module SystemAtriCure, Inc. · 2011
- 4 generations backK121507 Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012
- 3 generations backK140058 Atricure Cryo Module SystemAtriCure, Inc. · 2014 · Recalled
- 2 generations backK142203 Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014
- 1 generation backK152337 cryoFORM cryoICE cryoablation probeAtriCure, Inc. · 2016
- This deviceK251928 CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01)…Medinice S.A. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −14 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −13 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −12 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −11 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −10 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −9 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| −8 | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and… | Cryocath Technologies, Inc. | 2006 | 1 |
| −7 | K082074 | Atricure CRYO1 Cryo-Ablation Probe | AtriCure, Inc. | 2009 | 1 |
| −6 | K111042 | Atricure Cryo Module | AtriCure, Inc. | 2011 | — |
| −5 | K112072 | Atricure Cryo Module System | AtriCure, Inc. | 2011 | — |
| −4 | K121507 | Atricure Cryo Module System (Acm, CRYO1, and Cryoice) | AtriCure, Inc. | 2012 | — |
| −3 | K140058 | Atricure Cryo Module System | AtriCure, Inc. | 2014 | 2 |
| −2 | K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | AtriCure, Inc. | 2014 | — |
| −1 | K152337 | cryoFORM cryoICE cryoablation probe | AtriCure, Inc. | 2016 | — |
| 0 (this device) | K251928 | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo -… | Medinice S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 7 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K152337 | cryoFORM cryoICE cryoablation probeSummary page 5…Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH – Unit, Cryosurgical, Accessories III. PREDICATE DEVICE K152337 Atricure cryoICE cryoFORM cryoablation probe is the predicate device and has not been subject to a design-related recall. The re… | 2016 |
| † | K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | 2014 |
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 31 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 55 ancestors have a recall of any class.
- 1 other device also cites its predicate K152337.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 CoolCryo cryoapplicator is a single use, sterile device indicated for the cryosurgical treatment
for ablation of arrhythmic cardiac tissue by freezing target tissues, inducing an inflammatory
response (cryonecrosis) that blocks the electrical conduction pathway.
The CoolCryo cryoapplicator can be used in adults and is intended for use in the clinical
environment by trained healthcare professionals.
The CoolCryo control console is a nonsterile, reusable device which delivers cryogenic energy,
namely liquid nitrogen, to the CoolCryo cyroapplicator. The CoolCryo control console can be used
in adults and is intended for use in the clinical environment by trained healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251928 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251928: CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251928
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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