510(k) Report

510(k) · Cleared

Cleared

Cryogen Cryosurgical System

K964971510(k) TraditionalCleared Mar 28, 1997106-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

Cryogen, Inc. · GEH Unit, Cryosurgical, Accessories

Cleared on Mar 28, 1997 after a 106-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 395 devices in its family, counting itself, has a Class I recall. 394 later devices descend from it.

Decided
Mar 28, 1997
Review
106 days
Class
Class II
Product code
GEH
Recalls
None
Predicates
0

394 later devices descend from it, 1 citing it directly. 1 of the 395 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 1 descendant cleared1998: 1 descendant cleared2001: 1 descendant cleared2002: 2 descendants cleared2004: 6 descendants cleared2008: 15 descendants cleared2006: 14 descendants cleared2007: 6 descendants cleared2011: 9 descendants cleared2003: 1 descendant cleared2005: 6 descendants cleared2009: 8 descendants cleared2014: 17 descendants cleared2010: 4 descendants cleared2018: 25 descendants cleared2025: 35 descendants cleared2024: 35 descendants cleared2017: 18 descendants cleared2022: 22 descendants cleared2013: 9 descendants cleared2012: 13 descendants cleared2019: 20 descendants cleared2016: 14 descendants cleared2020: 27 descendants cleared2021: 22 descendants cleared2015: 7 descendants cleared2023: 27 descendants cleared, 1 with a Class I recall12026: 29 descendants cleared1995200020052010201520202025
  1. This deviceK964971 Cryogen Cryosurgical SystemCryogen, Inc. · 1997
  2. Descendant · cites it directly · 393 of its ownK972662 Cryogen Cryosurgical SystemCryogen, Inc. · 1997
  3. Descendant · 2 generations on · 392 of its ownK974320 Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998
  4. Descendant · 3 generations on · 340 of its ownK013946 Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002
  5. Descendant · 3 generations on · 268 of its ownK041340 Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery · 2004
  6. Descendant · 4 generations on · 251 of its ownK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004

Showing 5 of 394 descendants. See all descendants

Descendants cleared per year

1997: 11998: 12001: 12002: 22003: 12004: 62005: 62006: 142007: 62008: 152009: 82010: 42011: 92012: 132013: 92014: 172015: 72016: 142017: 182018: 252019: 202020: 272021: 222022: 222023: 272024: 352025: 352026: 29
1997high 35 (2024) · low 0 (1999)2026

Class I recalls in this family

  • K223095 Senhance Surgical System7 generations on · 2023

Most influential descendants

Showing 5 of 394 · See all
  • K972662Cryogen Cryosurgical SystemCryogen, Inc. · 1997 · cites it directly393descendants
  • K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998 · 2 generations on392descendants
  • K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002 · 3 generations on340descendants
  • K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery · 2004 · 3 generations on268descendants
  • K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc. · 2004 · 4 generations on251descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K964971Cryogen Cryosurgical SystemCryogen, Inc.1997—
+1K972662Cryogen Cryosurgical SystemCryogen, Inc.1997—
+2K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc.1998—
+3K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc.2002—
+3K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery2004—
+4K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200110
200220
200310
200460
200560
2006140
200760
2008150
200980
201040
201190
2012130
201390
2014170
201570
2016140
2017180
2018250
2019200
2020270
2021220
2022220
2023271
2024350
2025350
2026290
FIG. 1 — Lineage of K964971, 1997–2026Source: 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.

1 device in this family has a Class I recall. 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (394)

See all 394

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K972662Cryogen Cryosurgical SystemCryogen, Inc.1997393

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 7 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K972662 (Cryogen, Inc., 1997) has gone furthest, with 393 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 Cryogen, Inc.

4 FDA decisions under this applicant name. See the company

  • K003050Cryosurgical Unit and AccessoriesCryogen, Inc. · 2000
  • K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998
  • K972662Cryogen Cryosurgical SystemCryogen, Inc. · 1997

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/K964971 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964971: Cryogen Cryosurgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964971

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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