510(k) · Cleared
ClearedcryoFORM cryoICE cryoablation probe
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 Mar 22, 2016 as substantially equivalent to K142203 (AtriCure, Inc., 2014) and 1 other predicate after a 216-day review. Its family tree reaches back 14 generations to 1995. 2 later devices descend from it.
- Decided
- Mar 22, 2016
- Review
- 216 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K942299 (1995). 54 ancestors in all, the oldest K781302 (1978). 2 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 10 generations between
- 3 generations backK121507 Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012
- 2 generations backK140058 Atricure Cryo Module SystemAtriCure, Inc. · 2014 · Recalled
- 1 generation backK142203 Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014
- This deviceK152337 cryoFORM cryoICE cryoablation probeAtriCure, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK251928 CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01)…Medinice S.A. · 2026
- Descendant · cites it directly · 0 of its ownK180137 AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE…AtriCure, Inc. · 2018
Show all 14 generations
- Root · 14 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 13 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 12 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 11 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 10 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 9 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 8 generations backK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- 7 generations backK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
- 6 generations backK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · Recalled
- 5 generations backK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
- 4 generations backK112072 Atricure Cryo Module SystemAtriCure, Inc. · 2011
- 3 generations backK121507 Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012
- 2 generations backK140058 Atricure Cryo Module SystemAtriCure, Inc. · 2014 · Recalled
- 1 generation backK142203 Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014
- This deviceK152337 cryoFORM cryoICE cryoablation probeAtriCure, Inc. · 2016
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 |
|---|---|---|---|---|---|
| −14 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −13 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −12 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −11 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −10 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −9 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −8 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| −7 | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and… | Cryocath Technologies, Inc. | 2006 | 1 |
| −6 | K082074 | Atricure CRYO1 Cryo-Ablation Probe | AtriCure, Inc. | 2009 | 1 |
| −5 | K111042 | Atricure Cryo Module | AtriCure, Inc. | 2011 | — |
| −4 | K112072 | Atricure Cryo Module System | AtriCure, Inc. | 2011 | — |
| −3 | K121507 | Atricure Cryo Module System (Acm, CRYO1, and Cryoice) | AtriCure, Inc. | 2012 | — |
| −2 | K140058 | Atricure Cryo Module System | AtriCure, Inc. | 2014 | 2 |
| −1 | K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | AtriCure, Inc. | 2014 | — |
| 0 (this device) | K152337 | cryoFORM cryoICE cryoablation probe | AtriCure, Inc. | 2016 | — |
| +1 | K251928 | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo -… | Medinice S.A. | 2026 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 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 |
|---|---|---|---|
| * | K142203 | Atricure Cryo Module System; cryoICE cryoablation probeSummary page 4…lass II Product Code: GEH and OCL III. Predicate Device The primary predicate device, AtriCure cryoICE cryoablation probe (CRYO2), was cleared via 510(k) K142203 on December 8, 2014 under the Product Code GEH. A secondary predicate device, Heartport Maze System: Cryoprobe Set, was cleared… | 2014 |
| * | K970496 | Heartport Maze System: Cryoprobe SetSummary page 4…as cleared via 510(k) K142203 on December 8, 2014 under the Product Code GEH. A secondary predicate device, Heartport Maze System: Cryoprobe Set, was cleared via 510(k) K970496 on May 9, 1997 under the Product Code OCL. The predicate devices have not been subject to a design-related recall. No reference… | 1997 |
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 21 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 54 ancestors have a recall of any class.
- Of its descendants, K251928 (Medinice S.A., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K142203.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 cryoFORM 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152337: cryoFORM 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/K152337
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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