510(k) Report

510(k) · Cleared

Cleared

Crymed Cryo-Ablator

K040809510(k) TraditionalCleared May 21, 200453-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

Crymed Technologies, Inc. · GEH Unit, Cryosurgical, Accessories

Cleared on May 21, 2004 as substantially equivalent to K813024 (Wallach Surgical Devices, Inc., 1981) and 5 other predicates after a 53-day review. Its family tree reaches back 2 generations to 1984. 16 later devices descend from it.

Decided
May 21, 2004
Review
53 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K840536 (1984). 6 ancestors in all, the oldest K811390 (1981). 16 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1994: 1 other ancestor1981: 2 other ancestors2006: 1 descendant cleared2012: 1 descendant cleared2007: 2 descendants cleared2010: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant cleared2016: 3 descendants cleared2017: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2020: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant clearedK840536 · Cryo Surg 5900 · Frigitronics of Connecticut, Inc. · 1984K970995 · CMS Cryolite · Cryomedical Sciences, Inc. · 199719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 3 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant8 generations forward: 1 descendant9 generations forward: 1 descendant K970995 · CMS Cryolite · Cryomedical Sciences, Inc. · 1997K840536 · Cryo Surg 5900 · Frigitronics of Connecticut, Inc. · 19840+5
  1. Root · 2 generations backK840536 Cryo Surg 5900Frigitronics of Connecticut, Inc. · 1984
  2. 1 generation backK970995 CMS CryoliteCryomedical Sciences, Inc. · 1997
  3. This deviceK040809 Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004
  4. Descendant · cites it directly · 15 of its ownK060555 Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006
  5. Descendant · 2 generations on · 13 of its ownK070893 Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc. · 2007
  6. Descendant · 2 generations on · 11 of its ownK101825 Cryoballoon Ablation SystemC2 Therapeutics · 2010
  7. Descendant · 3 generations on · 10 of its ownK131523 Cryoballoon Focal Ablation SystemC2 Therapeutics · 2013 · Recalled
  8. Descendant · 4 generations on · 8 of its ownK151054 Coldplay Full CryoBalloon Ablation System and Coldplay Swipe…C2 Therapeutics, Inc. · 2015

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22010: 12012: 12013: 12015: 12016: 32017: 12018: 12019: 12020: 12021: 12024: 1
2006high 3 (2016) · low 0 (2008)2026

Most influential descendants

Showing 5 of 16 · See all
  • K060555Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006 · cites it directly15descendants
  • K070893Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc. · 2007 · 2 generations on13descendants
  • K101825Cryoballoon Ablation SystemC2 Therapeutics · 2010 · 2 generations on11descendants
  • K131523Cryoballoon Focal Ablation SystemC2 Therapeutics · 2013 · 3 generations on10descendants
  • K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2015 · 4 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K840536Cryo Surg 5900Frigitronics of Connecticut, Inc.1984—
−1K970995CMS CryoliteCryomedical Sciences, Inc.1997—
0 (this device)K040809Crymed Cryo-AblatorCrymed Technologies, Inc.2004—
+1K060555Spraygenix Cryo Ablation SystemCrymed Technologies, Inc.2006—
+2K070893Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc.2007—
+2K101825Cryoballoon Ablation SystemC2 Therapeutics2010—
+3K131523Cryoballoon Focal Ablation SystemC2 Therapeutics20132
+4K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon…C2 Therapeutics, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198120
199410
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
201010
201210
201310
201510
201630
201710
201810
201910
202010
202110
202410
FIG. 1 — Lineage of K040809, 1984–2024Source: 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? (6)

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
*K813024WA1000
Summary page 1
…: Applied for on 3/20/04 Predicate Devices Device Premarket Notification Wallach Surgical Devices WA1000 K813024 Figitronics Cryo-Plus TM K811390 Figitronics Cryo-SurgTMSystem 5900 K840536 Wa…
Wallach Surgical Devices, Inc.1981—
*K811390CCS100 Cryosurgical System
Summary page 1
…Premarket Notification Wallach Surgical Devices WA1000 K813024 Figitronics Cryo-Plus TM K811390 Figitronics Cryo-SurgTMSystem 5900 K840536 Wallach Surgical Devices UltraFreeze K935010 Co…
Frigitronics of Connecticut, Inc.1981—
*K840536Cryo Surg 5900
Summary page 1
…h Surgical Devices WA1000 K813024 Figitronics Cryo-Plus TM K811390 Figitronics Cryo-SurgTMSystem 5900 K840536 Wallach Surgical Devices UltraFreeze K935010 Cortex Technology's Cryopro Maxi and Cryopro Mini…
Frigitronics of Connecticut, Inc.1984—
*K935010Wallach Ultra Freeze
Summary page 1
…ronics Cryo-Plus TM K811390 Figitronics Cryo-SurgTMSystem 5900 K840536 Wallach Surgical Devices UltraFreeze K935010 Cortex Technology's Cryopro Maxi and Cryopro Mini K982280 CMS Cryolite…
Wallach Surgical Devices, Inc.1994—
*K982280Cryopro Maxi and Cryopro Mini
Summary page 1
…K840536 Wallach Surgical Devices UltraFreeze K935010 Cortex Technology's Cryopro Maxi and Cryopro Mini K982280 CMS Cryolite K970995 Device Description The Cryo-Ablator System is a cryosurgical dev…
Cortex Technology Aps1998—
*K970995CMS Cryolite
Summary page 1
…K935010 Cortex Technology's Cryopro Maxi and Cryopro Mini K982280 CMS Cryolite K970995 Device Description The Cryo-Ablator System is a cryosurgical device, consisting of an electronic console, cryo-catheter and…
Cryomedical Sciences, Inc.1997—

Also cleared against K813024: 1 other device →

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K060555Spraygenix Cryo Ablation SystemCrymed Technologies, Inc.200615
K113021Trufreeze System, Trufreeze Spray KitCSA Medical, Inc.20120
K072651Cryospray Ablation System, Model CC2-NamCSA Medical, Inc.20070

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 20 years and passes through 3 companies; a new generation was cleared every 13.2 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K060555 (Crymed Technologies, Inc., 2006) has gone furthest, with 15 descendants of its own.
  • 1 other device also cites its predicate K813024.

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—

What is it indicated for?

The CryMed Cryo-Ablator System is intended to be used as a cryosurgical tool for

destruction of unwanted tissue in the fields of dermatology, gynecology and general

surgery.

Indications for use as stated in the FDA summary.

Also cleared against K813024

1 other device cites the same predicate.

  • K060555Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006

More from Crymed Technologies, Inc.

2 FDA decisions under this applicant name. See the company

  • K060555Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006

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/K040809 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040809: Crymed Cryo-Ablator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040809

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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