510(k) · Cleared
Recalled · Class II · 2023Atricure Cryo Module System
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 Jan 24, 2014 as substantially equivalent to K111042 (AtriCure, Inc., 2011) and 2 other predicates after a 14-day review. Its family tree reaches back 12 generations to 1995. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 24, 2014
- Review
- 14 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 12 generations to K942299 (1995). 48 ancestors in all, the oldest K811390 (1981). 10 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 8 generations between
- 3 generations backK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
- 2 generations backK112072 Atricure Cryo Module SystemAtriCure, Inc. · 2011
- 1 generation backK121507 Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012
- This deviceK140058 Atricure Cryo Module SystemAtriCure, Inc. · 2014
- Descendant · cites it directly · 9 of its ownK142203 Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK180138 AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc. · 2018
- Descendant · 3 generations on · 3 of its ownK182565 AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK200697 AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE…AtriCure, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK152337 cryoFORM cryoICE cryoablation probeAtriCure, Inc. · 2016
Show all 12 generations
- Root · 12 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 11 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 10 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 9 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 8 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 7 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 6 generations backK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- 5 generations backK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
- 4 generations backK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · Recalled
- 3 generations backK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
- 2 generations backK112072 Atricure Cryo Module SystemAtriCure, Inc. · 2011
- 1 generation backK121507 Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012
- This deviceK140058 Atricure Cryo Module SystemAtriCure, Inc. · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014 · cites it directly9descendants
- K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc. · 2018 · 2 generations on4descendants
- K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc. · 2018 · 3 generations on3descendants
- K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation…AtriCure, Inc. · 2020 · 3 generations on2descendants
- K152337cryoFORM cryoICE cryoablation probeAtriCure, Inc. · 2016 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −11 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −10 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −9 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −8 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −7 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −6 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| −5 | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and… | Cryocath Technologies, Inc. | 2006 | 1 |
| −4 | K082074 | Atricure CRYO1 Cryo-Ablation Probe | AtriCure, Inc. | 2009 | 1 |
| −3 | K111042 | Atricure Cryo Module | AtriCure, Inc. | 2011 | — |
| −2 | K112072 | Atricure Cryo Module System | AtriCure, Inc. | 2011 | — |
| −1 | K121507 | Atricure Cryo Module System (Acm, CRYO1, and Cryoice) | AtriCure, Inc. | 2012 | — |
| 0 (this device) | K140058 | Atricure Cryo Module System | AtriCure, Inc. | 2014 | — |
| +1 | K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | AtriCure, Inc. | 2014 | — |
| +2 | K180138 | AtriCure cryoICE cryo-ablation probe (CRYO2) | AtriCure, Inc. | 2018 | — |
| +3 | K182565 | AtriCure cryoICE cryoSPHERE cryoablation probe | AtriCure, Inc. | 2018 | — |
| +3 | K200697 | AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE… | AtriCure, Inc. | 2020 | — |
| +2 | K152337 | cryoFORM cryoICE cryoablation probe | AtriCure, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 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 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? (3)
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 |
|---|---|---|---|
| * | K111042 | Atricure Cryo ModuleSummary page 1…, single use device. Cleared Device The device proposed for modification in this submission is the AtriCure Ciyo Module System (ACM, Ct'yol, and cryolCE) (K1 11042, K1 12072, and K121507). Device Description The AtriCure Cryo Module (ACM) unit is a non-sterile reusable electro-mecharic… | 2011 |
| * | K112072 | Atricure Cryo Module SystemSummary page 1…se device. Cleared Device The device proposed for modification in this submission is the AtriCure Ciyo Module System (ACM, Ct'yol, and cryolCE) (K1 11042, K1 12072, and K121507). Device Description The AtriCure Cryo Module (ACM) unit is a non-sterile reusable electro-mecharical and… | 2011 |
| * | K121507 | Atricure Cryo Module System (Acm, CRYO1, and Cryoice)Summary page 1…eared Device The device proposed for modification in this submission is the AtriCure Ciyo Module System (ACM, Ct'yol, and cryolCE) (K1 11042, K1 12072, and K121507). Device Description The AtriCure Cryo Module (ACM) unit is a non-sterile reusable electro-mecharical and pneumatic… | 2012 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142203 | Atricure Cryo Module System; cryoICE cryoablation probe | 2014 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 28, 2023 | Class II | Z-0927-2024 | Other | AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin… |
| Nov 28, 2023 | Class II | Z-0928-2024 | Other | AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin… |
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 1.7 years on median.
- 4 of the 48 ancestors have a recall of any class.
- Of its descendants, K142203 (AtriCure, Inc., 2014) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K111042.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The AtriCure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the AtriCure Cryo Module (ACM)-a non-sterile, reusable device-used with the Cryol cryo-ablation probe-a sterile, single use device-and/or the cryolCE cryo-ablation probe-a sterile, single use device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140058 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140058: Atricure Cryo Module System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140058
Report an extraction error
Are you the manufacturer?
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