510(k) · Cleared
ClearedAtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AtriCure, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Feb 15, 2018 as substantially equivalent to K142441 (AtriCure, Inc., 2014) and 1 other predicate after a 29-day review. Its family tree reaches back 15 generations to 1995.
- Decided
- Feb 15, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K942299 (1995). 56 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 deviceK180137 AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE…AtriCure, Inc. · 2018
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 deviceK180137 AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE…AtriCure, Inc. · 2018
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) | K180137 | AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM… | AtriCure, Inc. | 2018 | — |
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 |
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K142441 | cryoICE croablation probeSummary page 4…I Product Code: GEH III. Predicate Device The device proposed for modification in this submission is the AtriCure cryoICE cryo-ablation probe cleared via K142441 on October 29, 2014, and the AtriCure cryoICE cryoFORm cryo-ablation probe cleared via K152337 on March 22, 2016. The following… | 2014 |
| * | K152337 | cryoFORM cryoICE cryoablation probeSummary page 4…in this submission is the AtriCure cryoICE cryo-ablation probe cleared via K142441 on October 29, 2014, and the AtriCure cryoICE cryoFORm cryo-ablation probe cleared via K152337 on March 22, 2016. The following reference device was also used in this submission: x K142203 AtriCure cryoICE cry… | 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 23 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 56 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. 2018, 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?
AtriCure’s cryoICE cryo-ablation probes are sterile, single use devices intended for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180137 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180137: AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180137
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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