510(k) · Cleared
ClearedAtricure Cryo Module System; cryoICE cryoablation probe
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 Nov 25, 2014 as substantially equivalent to K082074 (AtriCure, Inc., 2009) and 5 other predicates after a 106-day review. Its family tree reaches back 13 generations to 1995. 9 later devices descend from it.
- Decided
- Nov 25, 2014
- Review
- 106 days
- Class
- Class II
- Product code
- GXH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K942299 (1995). 53 ancestors in all, the oldest K781302 (1978). 9 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 9 generations between
- 3 generations backK112072 Atricure Cryo Module SystemAtriCure, Inc. · 2011
- 2 generations backK121507 Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012
- 1 generation backK140058 Atricure Cryo Module SystemAtriCure, Inc. · 2014 · Recalled
- This deviceK142203 Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK180138 AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK182565 AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK200697 AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE…AtriCure, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK152337 cryoFORM cryoICE cryoablation probeAtriCure, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK251928 CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01)…Medinice S.A. · 2026
Show all 13 generations
- Root · 13 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 12 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 11 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 10 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 9 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 8 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 7 generations backK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- 6 generations backK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
- 5 generations backK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · Recalled
- 4 generations backK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
- 3 generations backK112072 Atricure Cryo Module SystemAtriCure, Inc. · 2011
- 2 generations backK121507 Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012
- 1 generation backK140058 Atricure Cryo Module SystemAtriCure, Inc. · 2014 · Recalled
- This deviceK142203 Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc. · 2018 · cites it directly4descendants
- K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc. · 2018 · 2 generations on3descendants
- K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation…AtriCure, Inc. · 2020 · 2 generations on2descendants
- K152337cryoFORM cryoICE cryoablation probeAtriCure, Inc. · 2016 · cites it directly2descendants
- K251928CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…Medinice S.A. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −12 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −11 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −10 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −9 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −8 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −7 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| −6 | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and… | Cryocath Technologies, Inc. | 2006 | 1 |
| −5 | K082074 | Atricure CRYO1 Cryo-Ablation Probe | AtriCure, Inc. | 2009 | 1 |
| −4 | K111042 | Atricure Cryo Module | AtriCure, Inc. | 2011 | — |
| −3 | K112072 | Atricure Cryo Module System | AtriCure, Inc. | 2011 | — |
| −2 | K121507 | Atricure Cryo Module System (Acm, CRYO1, and Cryoice) | AtriCure, Inc. | 2012 | — |
| −1 | K140058 | Atricure Cryo Module System | AtriCure, Inc. | 2014 | 2 |
| 0 (this device) | K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | AtriCure, Inc. | 2014 | — |
| +1 | K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2) | AtriCure, Inc. | 2018 | — |
| +2 | K182565 | AtriCure cryoICE cryoSPHERE cryoablation probe | AtriCure, Inc. | 2018 | — |
| +2 | K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE… | AtriCure, Inc. | 2020 | — |
| +1 | K152337 | cryoFORM cryoICE cryoablation probe | AtriCure, Inc. | 2016 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (6)
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 |
|---|---|---|---|
| * | K082074 | Atricure CRYO1 Cryo-Ablation ProbeSummary page 4…yogenic Surgical Device, 21 CFR 882.4250 Regulatory Class: Class II Product Code: GEH and GXH III. Predicate Devices AtriCure cryo-ablation probe K082074 AtriCure Cryo Module System K111042, K112072, K121507, and K140058 Cryomedical Instruments LTD. CryoStar™ System K031482 The pre… | 2009 |
| * | K111042 | Atricure Cryo ModuleSummary page 4…4250 Regulatory Class: Class II Product Code: GEH and GXH III. Predicate Devices AtriCure cryo-ablation probe K082074 AtriCure Cryo Module System K111042, K112072, K121507, and K140058 Cryomedical Instruments LTD. CryoStar™ System K031482 The predicate devices have not been subject… | 2011 |
| * | K112072 | Atricure Cryo Module SystemSummary page 4…ulatory Class: Class II Product Code: GEH and GXH III. Predicate Devices AtriCure cryo-ablation probe K082074 AtriCure Cryo Module System K111042, K112072, K121507, and K140058 Cryomedical Instruments LTD. CryoStar™ System K031482 The predicate devices have not been subject to a des… | 2011 |
| * | K121507 | Atricure Cryo Module System (Acm, CRYO1, and Cryoice)Summary page 4…lass: Class II Product Code: GEH and GXH III. Predicate Devices AtriCure cryo-ablation probe K082074 AtriCure Cryo Module System K111042, K112072, K121507, and K140058 Cryomedical Instruments LTD. CryoStar™ System K031482 The predicate devices have not been subject to a design-relat… | 2012 |
| * | K140058 | Atricure Cryo Module SystemSummary page 4…lass II Product Code: GEH and GXH III. Predicate Devices AtriCure cryo-ablation probe K082074 AtriCure Cryo Module System K111042, K112072, K121507, and K140058 Cryomedical Instruments LTD. CryoStar™ System K031482 The predicate devices have not been subject to a design-related recall. N… | 2014 |
| * | K031482 | Cryostar System, Comprising: a) Cryostar Console, B) Cryostar 1MM Cryoprobe, C) Cryostar…Summary page 4…Predicate Devices AtriCure cryo-ablation probe K082074 AtriCure Cryo Module System K111042, K112072, K121507, and K140058 Cryomedical Instruments LTD. CryoStar™ System K031482 The predicate devices have not been subject to a design-related recall. No reference devices were used in this submission.… | 2003 |
What descends from it? (9)
3 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 19 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 53 ancestors have a recall of any class.
- Of its descendants, K180138 (AtriCure, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K082074.
How does its category compare?
All GXH devicesGXH Device, Surgical, Cryogenic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The AtriCure Cryo Module is a non-sterile, reusable device which delivers cryogenic energy, namely nitrous oxide, to AtriCure’s cryo-ablation probes.
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. The probe is also intended for use in blocking pain by temporarily ablating peripheral nerves.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142203: Atricure Cryo Module System; cryoICE cryoablation probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142203
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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