510(k) Report

510(k) · Cleared

Cleared

Atricure Cryo Module System (Acm, CRYO1, and Cryoice)

K121507510(k) TraditionalCleared Jun 6, 201216-day reviewClass II21 CFR 878.4350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

AtriCure, Inc. · GEH Unit, Cryosurgical, Accessories

Cleared on Jun 6, 2012 as substantially equivalent to K112072 (AtriCure, Inc., 2011) after a 16-day review. Its family tree reaches back 11 generations to 1995. 11 later devices descend from it.

Decided
Jun 6, 2012
Review
16 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
1

Its longest line of descent runs back 11 generations to K942299 (1995). 47 ancestors in all, the oldest K811390 (1981). 11 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1981: 1 other ancestor1997: 7 other ancestors2003: 1 other ancestor2002: 3 other ancestors2001: 4 other ancestors1992: 2 other ancestors2000: 3 other ancestors1999: 3 other ancestors1998: 3 other ancestors1995: 4 other ancestors1994: 1 other ancestor1987: 1 other ancestor1988: 1 other ancestor1996: 1 other ancestor1991: 1 other ancestor2014: 2 descendants cleared2016: 1 descendant cleared2018: 3 descendants cleared2024: 1 descendant cleared2026: 1 descendant cleared2020: 1 descendant cleared2025: 1 descendant cleared2023: 1 descendant clearedK942299 · Endocare Cryotherapy System · Cytocare, Inc. · 1995K963826 · Endocare Crycare Cryosurgical System · Endocare, Inc. · 1996×2: 2 generations cleared close together, K973686 (1997), K980110 (1998) K011722 · Atricure Bipolar Coagulation System · AtriCure, Inc. · 2001K020919 · Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 · AtriCure, Inc. · 2002K040690 · Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console · Cryocath Technologies, Inc. · 2004K053436 · Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical Console · Cryocath Technologies, Inc. · 2006 · recalledK082074 · Atricure CRYO1 Cryo-Ablation Probe · AtriCure, Inc. · 2009 · recalled×2: 2 generations cleared close together, K111042 (2011), K112072 (2011) 19801990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor4 generations back: 1 other ancestor5 generations back: 5 other ancestors6 generations back: 5 other ancestors7 generations back: 14 other ancestors8 generations back: 5 other ancestors9 generations back: 5 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants K112072 · Atricure Cryo Module System · AtriCure, Inc. · 2011K111042 · Atricure Cryo Module · AtriCure, Inc. · 2011K082074 · Atricure CRYO1 Cryo-Ablation Probe · AtriCure, Inc. · 2009 · recalledK053436 · Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical Console · Cryocath Technologies, Inc. · 2006 · recalledK040690 · Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical Console · Cryocath Technologies, Inc. · 2004K020919 · Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 · AtriCure, Inc. · 2002K011722 · Atricure Bipolar Coagulation System · AtriCure, Inc. · 2001K980110 · Endocre Cryocare Cryosurgical System · Endocare, Inc. · 1998K973686 · Endocare Cryocare Cryosurgical System · Endocare, Inc. · 1997K963826 · Endocare Crycare Cryosurgical System · Endocare, Inc. · 1996K942299 · Endocare Cryotherapy System · Cytocare, Inc. · 1995−10−50
  1. Root · 11 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
  2. 7 generations between
  3. 3 generations backK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · Recalled
  4. 2 generations backK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
  5. 1 generation backK112072 Atricure Cryo Module SystemAtriCure, Inc. · 2011
  6. This deviceK121507 Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012
  7. Descendant · cites it directly · 10 of its ownK140058 Atricure Cryo Module SystemAtriCure, Inc. · 2014 · Recalled
  8. Descendant · cites it directly · 9 of its ownK142203 Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014
  9. Descendant · 2 generations on · 4 of its ownK180138 AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc. · 2018
  10. Descendant · 3 generations on · 3 of its ownK182565 AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc. · 2018
  11. Descendant · 3 generations on · 2 of its ownK200697 AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE…AtriCure, Inc. · 2020
Show all 11 generations
  1. Root · 11 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
  2. 10 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
  3. 9 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
  4. 8 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
  5. 7 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
  6. 6 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
  7. 5 generations backK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
  8. 4 generations backK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
  9. 3 generations backK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · Recalled
  10. 2 generations backK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
  11. 1 generation backK112072 Atricure Cryo Module SystemAtriCure, Inc. · 2011
  12. This deviceK121507 Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2014: 22016: 12018: 32020: 12023: 12024: 12025: 12026: 1
2014high 3 (2018) · low 0 (2015)2026

Most influential descendants

Showing 5 of 11 · See all
  • K140058Atricure Cryo Module SystemAtriCure, Inc. · 2014 · cites it directly10descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K942299Endocare Cryotherapy SystemCytocare, Inc.1995—
−10K963826Endocare Crycare Cryosurgical SystemEndocare, Inc.1996—
−9K973686Endocare Cryocare Cryosurgical SystemEndocare, Inc.1997—
−8K980110Endocre Cryocare Cryosurgical SystemEndocare, Inc.1998—
−7K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.2001—
−6K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc.2002—
−5K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.2004—
−4K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and…Cryocath Technologies, Inc.20061
−3K082074Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc.20091
−2K111042Atricure Cryo ModuleAtriCure, Inc.2011—
−1K112072Atricure Cryo Module SystemAtriCure, Inc.2011—
0 (this device)K121507Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc.2012—
+1K140058Atricure Cryo Module SystemAtriCure, Inc.20142
+1K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc.2014—
+2K180138AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc.2018—
+3K182565AtriCure cryoICE cryoSPHERE cryoablation probeAtriCure, Inc.2018—
+3K200697AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE…AtriCure, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198710
198810
199110
199220
199410
199540
199610
199770
199830
199930
200030
200140
200230
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201610
201830
202010
202310
202410
202510
202610
FIG. 1 — Lineage of K121507, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K112072Atricure Cryo Module System
Summary page 1
…le. single use device. Cleared Device The device proposed for modification in this submission is the Atriure Cryo Module System (ACM, Cryol, and cryolCE) (K1 12072). Device Description The Atriure Cryo Module (ACM) unit is a non-sterile reusable electro-mechanical and pneumatic c…
AtriCure, Inc.2011—

Also cleared against K112072: 3 other devices →

What descends from it? (11)

See all 11

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140058Atricure Cryo Module SystemAtriCure, Inc.201410
K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc.20149

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 17 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
  • 4 of the 47 ancestors have a recall of any class.
  • Of its descendants, K140058 (AtriCure, Inc., 2014) has gone furthest, with 10 descendants of its own.
  • 3 other devices also cite its predicate K112072.

How does its category compare?

All GEH devices

GEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · GEH

10in 2025

2007: 62008: 12009: 42010: 42011: 72012: 42013: 42014: 62015: 112016: 152017: 122018: 62019: 62020: 82021: 62022: 62023: 82024: 92025: 102026 (partial year): 8
2007high 15 (2016) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEH

77in 2025

2007: 71 days median2009: 121 days median2010: 86 days median2011: 91 days median2012: 96 days median2013: 76 days median2014: 42 days median2015: 72 days median2016: 60 days median2017: 83 days median2018: 42 days median2019: 115 days median2020: 113 days median2021: 206 days median2022: 56 days median2023: 136 days median2024: 85 days median2025: 77 days median2026 (partial year): 148 days median
2007high 206 (2021) · low 42 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEH

2in 2023

2007: 32008: 22009: 132010: 42012: 32014: 22018: 12019: 12020: 372023: 22026 (partial year): 2
2007high 37 (2020) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEH

171in 2025

2007: 232008: 292009: 212010: 1732011: 612012: 912013: 912014: 572015: 972016: 1432017: 2162018: 2082019: 4552020: 2772021: 2132022: 2302023: 1642024: 1412025: 171
2007high 455 (2019) · low 21 (2009)2025

MAUDE reports naming product code GEH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007671323
20081—229
200941211321
20104864173
2011791061
2012496391
2013476091
2014642257
20151172097
201615600143
201712830216
20186421208
201961151455
2020811337277
202162060213
20226560230
202381362164
20249850141
202510770171
202681482—

What is it indicated for?

The Atriure Cryo Module System is intended for use in the cryosurgical treatment of cardiac arrhythmias. The System consists of the Atriure 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.

Also cleared against K112072

3 other devices cite the same predicate.

  • K142203Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014
  • K133672Reprocessed Harmonic Ace Shears Without Adaptive Tissue TechnologyStryker Sustainability Solutions · 2014
  • K140058Atricure Cryo Module SystemAtriCure, Inc. · 20142 recalls

More from AtriCure, Inc.

97 FDA decisions under this applicant name. See the company

  • K263319ACHM30 AtriClip FLEX-Mini LAA Exclusion SystemAtriCure, Inc. · 2026
  • P100046/S021Synergy Ablation SystemAtriCure, Inc. · 2026
  • P200002/S015EPi- Sense ST Coagulation SystemAtriCure, Inc. · 2026
  • P100046/S020Synergy Ablation SystemAtriCure, Inc. · 2026
  • P200002/S014EPi-Sense and EPi-Sense ST Guided Coagulation SystemAtriCure, Inc. · 2026

Recent decisions in GEH

The GEH category page

  • K262420Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)Serpex Medical · 2026
  • K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical · 2026
  • K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH · 2026
  • K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH · 2026
  • K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V. · 2026

https://510kreport.com/device/K121507 · printed Nov 4, 2026

Cite this page

510(k) Report. “K121507: Atricure Cryo Module System (Acm, CRYO1, and Cryoice).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K121507

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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