510(k) · Cleared
ClearedcryoICE cryoXT cryoablation probe (cryoXT)
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 Apr 10, 2025 as substantially equivalent to K200697 (AtriCure, Inc., 2020) after a 59-day review. Its family tree reaches back 17 generations to 1995.
- Decided
- Apr 10, 2025
- Review
- 59 days
- Class
- Class II
- Product code
- GXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K942299 (1995). 57 ancestors in all, the oldest K781302 (1978). No later device cites it as a predicate yet.
- Root · 17 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 13 generations between
- 3 generations backK180138 AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc. · 2018
- 2 generations backK182565 AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc. · 2018
- 1 generation backK200697 AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE…AtriCure, Inc. · 2020
- This deviceK250371 cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc. · 2025
Show all 17 generations
- Root · 17 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 16 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 15 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 14 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 13 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 12 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 11 generations backK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- 10 generations backK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
- 9 generations backK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · Recalled
- 8 generations backK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
- 7 generations backK112072 Atricure Cryo Module SystemAtriCure, Inc. · 2011
- 6 generations backK121507 Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012
- 5 generations backK140058 Atricure Cryo Module SystemAtriCure, Inc. · 2014 · Recalled
- 4 generations backK142203 Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014
- 3 generations backK180138 AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc. · 2018
- 2 generations backK182565 AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc. · 2018
- 1 generation backK200697 AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE…AtriCure, Inc. · 2020
- This deviceK250371 cryoICE cryoXT cryoablation probe (cryoXT)AtriCure, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −16 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −15 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −14 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −13 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −12 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −11 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| −10 | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and… | Cryocath Technologies, Inc. | 2006 | 1 |
| −9 | K082074 | Atricure CRYO1 Cryo-Ablation Probe | AtriCure, Inc. | 2009 | 1 |
| −8 | K111042 | Atricure Cryo Module | AtriCure, Inc. | 2011 | — |
| −7 | K112072 | Atricure Cryo Module System | AtriCure, Inc. | 2011 | — |
| −6 | K121507 | Atricure Cryo Module System (Acm, CRYO1, and Cryoice) | AtriCure, Inc. | 2012 | — |
| −5 | K140058 | Atricure Cryo Module System | AtriCure, Inc. | 2014 | 2 |
| −4 | K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | AtriCure, Inc. | 2014 | — |
| −3 | K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2) | AtriCure, Inc. | 2018 | — |
| −2 | K182565 | AtriCure cryoICE cryoSPHERE cryoablation probe | AtriCure, Inc. | 2018 | — |
| −1 | K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE… | AtriCure, Inc. | 2020 | — |
| 0 (this device) | K250371 | cryoICE cryoXT cryoablation probe (cryoXT) | AtriCure, Inc. | 2025 | — |
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 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 K243157 AtriCure cryoICE BOX (ACM)score 12.2 · 14 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 |
|---|---|---|---|
| * | K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation…Summary page 5…Classif ication Panel: Neurodiagnostic and Neurosurgical Devices Predicate Device: cryoICE® cryoablation probe (CRYO2) (cleared via 510(k) K200697, March 17, 2020) Reference Device: cryoICE® cryoSPHERE® cryoablation probe (CR… | 2020 |
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 30 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 57 ancestors have a recall of any class.
- 1 other device also cites its predicate K200697.
How does its category compare?
All GXH devicesGXH Device, Surgical, Cryogenic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
AtriCure’s cryolCE cryoXT cryoablation probes are intended for use to temporarily block pain by ablating peripheral nerves performed by freezing target tissues, creating an inflammatory response (cryonecrosis).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250371 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250371: cryoICE cryoXT cryoablation probe (cryoXT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250371
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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