510(k) · Cleared
ClearedAtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AtriCure, Inc. · GXH Device, Surgical, Cryogenic
Cleared on Dec 23, 2020 as substantially equivalent to K180138 (AtriCure, Inc., 2018) and 1 other predicate after a 281-day review. Its family tree reaches back 16 generations to 1995. 2 later devices descend from it.
- Decided
- Dec 23, 2020
- Review
- 281 days
- Class
- Class II
- Product code
- GXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K942299 (1995). 56 ancestors in all, the oldest K781302 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 12 generations between
- 3 generations backK142203 Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014
- 2 generations backK180138 AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc. · 2018
- 1 generation backK182565 AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc. · 2018
- This deviceK200697 AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE…AtriCure, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK250371 cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233170 cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+…AtriCure, Inc. · 2023
Show all 16 generations
- Root · 16 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 15 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 14 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 13 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 12 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 11 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 10 generations backK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- 9 generations backK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
- 8 generations backK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · Recalled
- 7 generations backK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
- 6 generations backK112072 Atricure Cryo Module SystemAtriCure, Inc. · 2011
- 5 generations backK121507 Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012
- 4 generations backK140058 Atricure Cryo Module SystemAtriCure, Inc. · 2014 · Recalled
- 3 generations backK142203 Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014
- 2 generations backK180138 AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc. · 2018
- 1 generation backK182565 AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc. · 2018
- This deviceK200697 AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE…AtriCure, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −15 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −14 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −13 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −12 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −11 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −10 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| −9 | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and… | Cryocath Technologies, Inc. | 2006 | 1 |
| −8 | K082074 | Atricure CRYO1 Cryo-Ablation Probe | AtriCure, Inc. | 2009 | 1 |
| −7 | K111042 | Atricure Cryo Module | AtriCure, Inc. | 2011 | — |
| −6 | K112072 | Atricure Cryo Module System | AtriCure, Inc. | 2011 | — |
| −5 | K121507 | Atricure Cryo Module System (Acm, CRYO1, and Cryoice) | AtriCure, Inc. | 2012 | — |
| −4 | K140058 | Atricure Cryo Module System | AtriCure, Inc. | 2014 | 2 |
| −3 | K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | AtriCure, Inc. | 2014 | — |
| −2 | K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2) | AtriCure, Inc. | 2018 | — |
| −1 | K182565 | AtriCure cryoICE cryoSPHERE cryoablation probe | AtriCure, Inc. | 2018 | — |
| 0 (this device) | K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE… | AtriCure, Inc. | 2020 | — |
| +1 | K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | AtriCure, Inc. | 2025 | — |
| +1 | K233170 | cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+… | AtriCure, Inc. | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 GXH? 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 GXH device
- #1 K250371 cryoICE cryoXT cryoablation probe (cryoXT)score 13.9 · 17 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 |
|---|---|---|---|
| * | K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2)Summary page 5…enic Surgical Device (21 CFR 878.4250) Regulatory Class: Class II Product Code: GXH III. Predicate Device Predicate Device: K180138 AtriCure® cryoICE® cryoablation probe (Cryo2) K182565 AtriCure® cryoICE® cryoSPHERE™ cryoablation probe (CryoS, CryoS-L) IV.… | 2018 |
| * | K182565 | AtriCure cryoICE cryoSPHERE cryoablation probeSummary page 5…ss: Class II Product Code: GXH III. Predicate Device Predicate Device: K180138 AtriCure® cryoICE® cryoablation probe (Cryo2) K182565 AtriCure® cryoICE® cryoSPHERE™ cryoablation probe (CryoS, CryoS-L) IV. Device Description Cryo2 The cryosurgical handpi… | 2018 |
What descends from it? (2)
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 25 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 56 ancestors have a recall of any class.
- Of its descendants, K250371 (AtriCure, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K180138.
How does its category compare?
All GXH devicesGXH Device, Surgical, Cryogenic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · GXH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXH
52in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXH
No recall names GXH since 2007.
Adverse event reports per year · GXH
5in 2025
MAUDE reports naming product code GXH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 3 | 52 | 0 | 14 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 6 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 2 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For Adult Patients AtriCure’s Cryo2 cryoICE cryoablation 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. The Cryo2 cryoICE cryo-ablation probes are also intended for use to temporarily block pain by ablating peripheral nerves. For Adolescent Patients The Cryo2 cryoICE…
Read the full statement (218 words)
For Adult Patients
AtriCure’s Cryo2 cryoICE cryoablation 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.
The Cryo2 cryoICE cryo-ablation probes are also intended for use to temporarily block pain by ablating peripheral nerves.
For Adolescent Patients
The Cryo2 cryoICE cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization1 in adolescent patients of at least 12 years of age.
1Direct visualization, in this context, requires that the surgeon is able to see the targeted tissue for cryoablation directly or with assistance from a camera, endoscope or other similar optical technology.
For Adult Patients
AtriCure’s cryoICE cryoSPHERE cryoablation probes are sterile, single use devices intended for use performed by freezing target tissues, creating an inflammatory response (cryonecrosis) for blocking pain by temporarily ablating peripheral nerves.
For Adolescent Patients
The cryoICE cryoSPHERE cryo-ablation probes are intended for use to temporarily block pain by ablating intercostal nerves under direct visualization1 in adolescent patients of at least 12 years of age.
1Direct visualization, in this context, requires that the surgeon is able to see the targeted tissue for cryoablation directly or with assistance from a camera, endoscope or other similar optical technology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200697: AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200697
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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