510(k) · Cleared
Recalled · Class II · 2014Atricure CRYO1 Cryo-Ablation 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 2, 2009 as substantially equivalent to K811390 (Frigitronics of Connecticut, Inc., 1981) and 2 other predicates after a 222-day review. Its family tree reaches back 8 generations to 1995. 16 later devices descend from it. It has been recalled once.
- Decided
- Mar 2, 2009
- Review
- 222 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 8 generations to K942299 (1995). 44 ancestors in all, the oldest K811390 (1981). 16 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 7 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 6 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- 5 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 4 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- 3 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- 2 generations backK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- 1 generation backK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
- This deviceK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009
- Descendant · cites it directly · 14 of its ownK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
- Descendant · 2 generations on · 13 of its ownK112072 Atricure Cryo Module SystemAtriCure, Inc. · 2011
- Descendant · 3 generations on · 11 of its ownK121507 Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012
- Descendant · 2 generations on · 10 of its ownK140058 Atricure Cryo Module SystemAtriCure, Inc. · 2014 · Recalled
- Descendant · cites it directly · 9 of its ownK142203 Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K111042Atricure Cryo ModuleAtriCure, Inc. · 2011 · cites it directly14descendants
- K112072Atricure Cryo Module SystemAtriCure, Inc. · 2011 · 2 generations on13descendants
- K121507Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012 · 3 generations on11descendants
- K140058Atricure Cryo Module SystemAtriCure, Inc. · 2014 · 2 generations on10descendants
- K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −7 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −6 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| −5 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| −4 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| −3 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| −2 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| −1 | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and… | Cryocath Technologies, Inc. | 2006 | 1 |
| 0 (this device) | K082074 | Atricure CRYO1 Cryo-Ablation Probe | AtriCure, Inc. | 2009 | — |
| +1 | K111042 | Atricure Cryo Module | AtriCure, Inc. | 2011 | — |
| +2 | 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 | — |
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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 4 | 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 |
|---|---|---|---|
| * | K811390 | CCS100 Cryosurgical SystemSummary page 1…Predicate Devices The predicate devices for the Cryol cryo-ablation probe are the frigitronics CCS-200 Cardiac Cryosurgical System 3011 Maze Linear Probe (K811390), the Heartport Maze System (K970496) and the CryoCath SurgiFrost Cryosurgical 10cm Device (K053436). Device Descr… | 1981 |
| * | K970496 | Heartport Maze System: Cryoprobe SetSummary page 1…ces for the Cryol cryo-ablation probe are the frigitronics CCS-200 Cardiac Cryosurgical System 3011 Maze Linear Probe (K811390), the Heartport Maze System (K970496) and the CryoCath SurgiFrost Cryosurgical 10cm Device (K053436). Device Description The Cryol cryo-ablation probe… | 1997 |
| * | K053436 | Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Summary page 1…Cardiac Cryosurgical System 3011 Maze Linear Probe (K811390), the Heartport Maze System (K970496) and the CryoCath SurgiFrost Cryosurgical 10cm Device (K053436). Device Description The Cryol cryo-ablation probe is a sterile, single use, cryosurgical device to be used in con… | 2006 |
What descends from it? (16)
See all 163 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 21, 2014 | Class II | Z-0895-2015 | Packaging process control | Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 44 ancestors have a recall of any class.
- Of its descendants, K111042 (AtriCure, Inc., 2011) has gone furthest, with 14 descendants of its own.
- 5 other devices also cite its predicate K811390.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Cryol cryo-ablation probe is a sterile, single use device intended for use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes 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/K082074 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082074: Atricure CRYO1 Cryo-Ablation Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082074
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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