510(k) Report

510(k) · Cleared

Cleared

Cryogen Cardiac Cryosurgical System

K974320510(k) TraditionalCleared Feb 3, 199878-day reviewClass II21 CFR 878.4400

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

Cryogen, Inc. · OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Cleared on Feb 3, 1998 as substantially equivalent to K811390 (Frigitronics of Connecticut, Inc., 1981) and 3 other predicates after a 78-day review. Its family tree reaches back 2 generations to 1981. 1 of the 400 devices in its family, counting itself, has a Class I recall. 392 later devices descend from it.

Decided
Feb 3, 1998
Review
78 days
Class
Class II
Product code
OCL
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K811390 (1981). 7 ancestors in all. 392 later devices descend from it, 3 citing it directly. 1 of the 400 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1997: 2 other ancestors1988: 1 other ancestor1995: 1 other ancestor1991: 1 other ancestor2001: 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 clearedK811390 · CCS100 Cryosurgical System · Frigitronics of Connecticut, Inc. · 1981K972662 · Cryogen Cryosurgical System · Cryogen, Inc. · 199719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 12 descendants3 generations forward: 24 descendants4 generations forward: 63 descendants5 generations forward: 60 descendants, 1 with a Class I recall16 generations forward: 54 descendants7 generations forward: 45 descendants8 generations forward: 48 descendants9 generations forward: 30 descendants10 generations forward: 24 descendants11 generations forward: 19 descendants12 generations forward: 9 descendants13 generations forward: 1 descendant K972662 · Cryogen Cryosurgical System · Cryogen, Inc. · 1997K811390 · CCS100 Cryosurgical System · Frigitronics of Connecticut, Inc. · 19810+5+10
  1. Root · 2 generations backK811390 CCS100 Cryosurgical SystemFrigitronics of Connecticut, Inc. · 1981
  2. 1 generation backK972662 Cryogen Cryosurgical SystemCryogen, Inc. · 1997
  3. This deviceK974320 Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998
  4. Descendant · cites it directly · 340 of its ownK013946 Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002
  5. Descendant · cites it directly · 268 of its ownK041340 Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery · 2004
  6. Descendant · 2 generations on · 251 of its ownK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
  7. Descendant · 3 generations on · 231 of its ownK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
  8. Descendant · 3 generations on · 230 of its ownK050369 Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc. · 2005 · Recalled

Showing 5 of 392 descendants. See all descendants

Descendants cleared per year

2001: 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
2001high 35 (2024) · low 1 (2001)2026

Class I recalls in this family

  • K223095 Senhance Surgical System5 generations on · 2023

Most influential descendants

Showing 5 of 392 · See all
  • K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002 · cites it directly340descendants
  • K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery · 2004 · cites it directly268descendants
  • K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc. · 2004 · 2 generations on251descendants
  • K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Intuitive Surgical, Inc. · 2005 · 3 generations on231descendants
  • K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc. · 2005 · 3 generations on230descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K811390CCS100 Cryosurgical SystemFrigitronics of Connecticut, Inc.1981—
−1K972662Cryogen Cryosurgical SystemCryogen, Inc.1997—
0 (this device)K974320Cryogen Cardiac Cryosurgical SystemCryogen, Inc.1998—
+1K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc.2002—
+1K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery2004—
+2K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models…Intuitive Surgical, Inc.2004—
+3K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover…Intuitive Surgical, Inc.20052
+3K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc.200551

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199110
199510
199720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
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 K974320, 1981–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

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 OCL device

  1. #1 K252056 Isolator® Synergy™ EnCompass Clamp and Guide…score 13.0 · 12 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? (4)

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
…al Unit and Accessories Classification name: Cryosurgical Unit and Accessories (21 CFR 878.4350) Predicate devices Device Premarket ‘ Notification Frigitronics CCS 100 K811390 Spembly Cardiac Cryounit and Cryoprobes K874367 Heartport Maze System: Cryoprobe Set K970496 CryoGen Cryosurgical System K972662…
Frigitronics of Connecticut, Inc.1981—
*K874367Various Cardiac Cryoprobes Having Dia. & Cos. Diff
Summary page 1
…yosurgical Unit and Accessories (21 CFR 878.4350) Predicate devices Device Premarket ‘ Notification Frigitronics CCS 100 K811390 Spembly Cardiac Cryounit and Cryoprobes K874367 Heartport Maze System: Cryoprobe Set K970496 CryoGen Cryosurgical System K972662 Device description & Principle of Operation Th…
Spembly Medical, Ltd.1988—
*K970496Heartport Maze System: Cryoprobe Set
Summary page 1
…4350) Predicate devices Device Premarket ‘ Notification Frigitronics CCS 100 K811390 Spembly Cardiac Cryounit and Cryoprobes K874367 Heartport Maze System: Cryoprobe Set K970496 CryoGen Cryosurgical System K972662 Device description & Principle of Operation The CryoGen Cardiac Cryosurgery System consists…
Heartport, Inc.1997—
*K972662Cryogen Cryosurgical System
Summary page 1
…rket ‘ Notification Frigitronics CCS 100 K811390 Spembly Cardiac Cryounit and Cryoprobes K874367 Heartport Maze System: Cryoprobe Set K970496 CryoGen Cryosurgical System K972662 Device description & Principle of Operation The CryoGen Cardiac Cryosurgery System consists of three components: the disposable…
Cryogen, Inc.1997—

Also cleared against K811390: 5 other devices →

What descends from it? (392)

See all 392

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

NumberDeviceApplicantDecidedDescendants
K013946Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc.2002340
K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery2004268
K011722Atricure Bipolar Coagulation SystemAtriCure, Inc.200192

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 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 16.3 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K013946 (Afx, Inc., 2002) has gone furthest, with 340 descendants of its own.
  • 5 other devices also cite its predicate K811390.

How does its category compare?

All OCL devices

OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OCL

1in 2025

2007: 32008: 52009: 22010: 22011: 22012: 62013: 22014: 12017: 12018: 22019: 62020: 12021: 22022: 22024: 12025: 1
2007high 6 (2012) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCL

85in 2019

2007: 139 days median2008: 81 days median2012: 75 days median2019: 85 days median
2007high 139 (2007) · low 75 (2012)2026

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

Recalls per year · OCL

1in 2021

2008: 12009: 12010: 22013: 12016: 12019: 42020: 42021: 1
2007high 4 (2019) · low 0 (2007)2026

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

Adverse event reports per year · OCL

46in 2025

2009: 82010: 232011: 212012: 212013: 132014: 152015: 312016: 762017: 552018: 612019: 492020: 372021: 632022: 592023: 992024: 592025: 46
2007high 99 (2023) · low 0 (2007)2025

MAUDE reports naming product code OCL, 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
2007313900
200858110
20092—18
20102—223
20112—021
2012675021
20132—113
20141—015
20150—031
20160—176
20171—055
20182—061
2019685449
20201—437
20212—163
20222—059
20230—099
20241—059
20251—046
20260—0—

What is it indicated for?

The CryoGen Cardiac Cryosurgical System is indicated for use in minimaily invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The cardiac cryoprobes freeze the target tissue and block the electrical conduction pathway by creating an inflammatory response, or cryonecrosis.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K811390

5 other devices cite the same predicate.

  • K111042Atricure Cryo ModuleAtriCure, Inc. · 2011
  • K082074Atricure CRYO1 Cryo-Ablation ProbeAtriCure, Inc. · 20091 recall
  • K060555Spraygenix Cryo Ablation SystemCrymed Technologies, Inc. · 2006
  • K040809Crymed Cryo-AblatorCrymed Technologies, Inc. · 2004
  • K972662Cryogen Cryosurgical SystemCryogen, Inc. · 1997

More from Cryogen, Inc.

4 FDA decisions under this applicant name. See the company

  • K003050Cryosurgical Unit and AccessoriesCryogen, Inc. · 2000
  • K972662Cryogen Cryosurgical SystemCryogen, Inc. · 1997
  • K964971Cryogen Cryosurgical SystemCryogen, Inc. · 1997

Recent decisions in OCL

The OCL category page

  • K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc. · 2025
  • K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc. · 2024
  • K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator®…AtriCure, Inc. · 2022
  • K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation DeviceMedtronic, Inc. · 2022
  • K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc. · 2021

https://510kreport.com/device/K974320 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974320: Cryogen Cardiac 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/K974320

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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