510(k) Report

510(k) · Cleared

Cleared

Atricure Cryo Module

K111042510(k) TraditionalCleared May 26, 201141-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 May 26, 2011 as substantially equivalent to K811390 (Frigitronics of Connecticut, Inc., 1981) and 1 other predicate after a 41-day review. Its family tree reaches back 9 generations to 1995. 14 later devices descend from it.

Decided
May 26, 2011
Review
41 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
2

Its longest line of descent runs back 9 generations to K942299 (1995). 45 ancestors in all, the oldest K811390 (1981). 14 later devices descend from it, 3 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: 3 descendants cleared2011: 1 descendant cleared2012: 1 descendant 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 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 5 other ancestors4 generations back: 5 other ancestors5 generations back: 14 other ancestors6 generations back: 5 other ancestors7 generations back: 5 other ancestors 1 generation forward: 3 descendants2 generations forward: 5 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants K082074 · 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. · 1995−50
  1. Root · 9 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
  2. 5 generations between
  3. 3 generations backK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
  4. 2 generations backK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
  5. 1 generation backK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · Recalled
  6. This deviceK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011
  7. Descendant · cites it directly · 13 of its ownK112072 Atricure Cryo Module SystemAtriCure, Inc. · 2011
  8. Descendant · 2 generations on · 11 of its ownK121507 Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012
  9. Descendant · cites it directly · 10 of its ownK140058 Atricure Cryo Module SystemAtriCure, Inc. · 2014 · Recalled
  10. Descendant · cites it directly · 9 of its ownK142203 Atricure Cryo Module System; cryoICE cryoablation probeAtriCure, Inc. · 2014
  11. Descendant · 2 generations on · 4 of its ownK180138 AtriCure cryoICE cryo-ablation probe (CRYO2)AtriCure, Inc. · 2018
Show all 9 generations
  1. Root · 9 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
  2. 8 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
  3. 7 generations backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
  4. 6 generations backK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
  5. 5 generations backK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
  6. 4 generations backK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
  7. 3 generations backK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
  8. 2 generations backK053436 Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte…Cryocath Technologies, Inc. · 2006 · Recalled
  9. 1 generation backK082074 Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 2009 · Recalled
  10. This deviceK111042 Atricure Cryo ModuleAtriCure, Inc. · 2011

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12014: 32016: 12018: 32020: 12023: 12024: 12025: 12026: 1
2011high 3 (2014) · low 0 (2013)2026

Most influential descendants

Showing 5 of 14 · See all
  • K112072Atricure Cryo Module SystemAtriCure, Inc. · 2011 · cites it directly13descendants
  • K121507Atricure Cryo Module System (Acm, CRYO1, and Cryoice)AtriCure, Inc. · 2012 · 2 generations on11descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K942299Endocare Cryotherapy SystemCytocare, Inc.1995—
−8K963826Endocare Crycare Cryosurgical SystemEndocare, Inc.1996—
−7K973686Endocare Cryocare Cryosurgical SystemEndocare, Inc.1997—
−6K980110Endocre Cryocare Cryosurgical SystemEndocare, Inc.1998—
−5K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.2001—
−4K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc.2002—
−3K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.2004—
−2K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and…Cryocath Technologies, Inc.20061
−1K082074Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc.20091
0 (this device)K111042Atricure Cryo ModuleAtriCure, Inc.2011—
+1K112072Atricure Cryo Module SystemAtriCure, Inc.2011—
+2K121507Atricure 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—

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
201110
201210
201430
201610
201830
202010
202310
202410
202510
202610
FIG. 1 — Lineage of K111042, 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K811390CCS100 Cryosurgical System
Summary page 1
…device. Predicate Devices The predicate devices for the AtriCure Cryo Module are the AtniCure firigitronics OCS- 200 Cardiac Cryosurgical System (K81 1390) and the AtriCure Cryol cryo-ablation probe (K082074). Device Description The AtriCure Cryo Module (ACM) unit is a…
Frigitronics of Connecticut, Inc.1981—
*K082074Atricure CRYO1 Cryo-Ablation Probe
Summary page 1
…ces for the AtriCure Cryo Module are the AtniCure firigitronics OCS- 200 Cardiac Cryosurgical System (K81 1390) and the AtriCure Cryol cryo-ablation probe (K082074). Device Description The AtriCure Cryo Module (ACM) unit is a non-sterile reusable electro-mechanical and pneumati…
AtriCure, Inc.20091

Also cleared against K811390: 5 other devices →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K112072Atricure Cryo Module SystemAtriCure, Inc.201113
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 16 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
  • 4 of the 45 ancestors have a recall of any class.
  • Of its descendants, K112072 (AtriCure, Inc., 2011) has gone furthest, with 13 descendants of its own.
  • 5 other devices also cite its predicate K811390.

How does its category compare?

All GEH devices

GEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 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 cryc-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 K811390

5 other devices cite the same predicate.

  • K082074Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 20091 recall
  • K060555Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006
  • K040809Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004
  • K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998
  • K972662Cryogen Cryosurgical SystemCryogen, Inc. · 1997

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/K111042 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111042: Atricure Cryo Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111042

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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