510(k) Report

510(k) · Cleared

Recalled · 2008

Cryocare Surgical System

K011074510(k) TraditionalCleared Jan 25, 2002291-day reviewClass II21 CFR 878.4350Recalls 2

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

Endocare, Inc. · GEH Unit, Cryosurgical, Accessories

Cleared on Jan 25, 2002 after a 291-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 56 later devices descend from it. It has been recalled 2 times.

Decided
Jan 25, 2002
Review
291 days
Class
Class II
Product code
GEH
Recalls
2
Predicates
0

56 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2006: 2 descendants cleared2015: 3 descendants cleared2010: 2 descendants cleared2003: 1 descendant cleared2008: 1 descendant cleared2016: 4 descendants cleared2005: 1 descendant cleared2024: 7 descendants cleared2012: 2 descendants cleared2013: 1 descendant cleared2017: 2 descendants cleared2020: 7 descendants cleared2014: 1 descendant cleared2023: 8 descendants cleared2018: 2 descendants cleared2025: 4 descendants cleared2019: 1 descendant cleared2021: 3 descendants cleared2022: 1 descendant cleared2026: 2 descendants cleared200020052010201520202025
  1. This deviceK011074 Cryocare Surgical SystemEndocare, Inc. · 2002
  2. Descendant · cites it directly · 54 of its ownK023757 Cryocare Surgical System, Model Cryo 20Endocare, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 39 of its ownK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
  4. Descendant · 3 generations on · 38 of its ownK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
  5. Descendant · 4 generations on · 29 of its ownK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
  6. Descendant · 5 generations on · 13 of its ownK163105 Emprint Ablation SystemCovidien, LLC · 2016 · Recalled

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12005: 12006: 22008: 12010: 22012: 22013: 12014: 12015: 32016: 42017: 22018: 22019: 12020: 72021: 32022: 12023: 82024: 72025: 42026: 2
2002high 8 (2023) · low 0 (2004)2026

Most influential descendants

Showing 5 of 56 · See all
  • K023757Cryocare Surgical System, Model Cryo 20Endocare, Inc. · 2002 · cites it directly54descendants
  • K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010 · 2 generations on39descendants
  • K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012 · 3 generations on38descendants
  • K133821Emprint Ablation SystemCovidien, LLC · 2014 · 4 generations on29descendants
  • K163105Emprint Ablation SystemCovidien, LLC · 2016 · 5 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011074Cryocare Surgical SystemEndocare, Inc.2002—
+1K023757Cryocare Surgical System, Model Cryo 20Endocare, Inc.20022
+2K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc.2010—
+3K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc.2012—
+4K133821Emprint Ablation SystemCovidien, LLC20147
+5K163105Emprint Ablation SystemCovidien, LLC20163

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200510
200620
200810
201020
201220
201310
201410
201530
201640
201720
201820
201910
202070
202130
202210
202380
202470
202540
202620
FIG. 1 — Lineage of K011074, 2002–2026Source: 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), 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

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  2. #2 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (56)

See all 56

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

NumberDeviceApplicantDecidedDescendants
K023757Cryocare Surgical System, Model Cryo 20Endocare, Inc.200254
K141110Cryocare CS Surgical SystemHealthtronics20157
K042096Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating SystemMisonix, Inc.20062

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 5, 2008Not classifiedZ-1401-2010OtherEndocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes was issued to refocus attention on the…
Dec 5, 2008Not classifiedZ-1400-2010OtherEndocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes was issued to refocus attention on the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K023757 (Endocare, Inc., 2002) has gone furthest, with 54 descendants of its own.

How does its category compare?

All GEH devices

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

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—

More from Endocare, Inc.

22 FDA decisions under this applicant name. See the company

  • K101333Cryocare CS Surgical SystemEndocare, Inc. · 20102 recalls
  • K062175Cryocare CN2 SystemEndocare, Inc. · 2006
  • K060279Cryocare CS Surgical SystemEndocare, Inc. · 20063 recalls
  • K050347Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005
  • K032333Cryocare CS Surgical SystemEndocare, Inc. · 2003

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/K011074 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011074: Cryocare Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011074

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026