510(k) Report

510(k) · Cleared

Cleared

Cryocare Cardiac Surgical System

K011040510(k) TraditionalCleared Jun 15, 200171-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

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

Cleared on Jun 15, 2001 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 104 later devices descend from it.

Decided
Jun 15, 2001
Review
71 days
Class
Class II
Product code
OCL
Recalls
None
Predicates
0

104 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2002: 3 descendants cleared2004: 4 descendants cleared2006: 13 descendants cleared2008: 10 descendants cleared2003: 3 descendants cleared2007: 5 descendants cleared2005: 2 descendants cleared2012: 7 descendants cleared2009: 4 descendants cleared2011: 4 descendants cleared2010: 4 descendants cleared2019: 8 descendants cleared2018: 5 descendants cleared2014: 5 descendants cleared2013: 3 descendants cleared2021: 2 descendants cleared2022: 3 descendants cleared2020: 2 descendants cleared2016: 1 descendant cleared2024: 6 descendants cleared2017: 1 descendant cleared2026: 4 descendants cleared2025: 2 descendants cleared2015: 1 descendant cleared2023: 2 descendants cleared200020052010201520202025
  1. This deviceK011040 Cryocare Cardiac Surgical SystemEndocare, Inc. · 2001
  2. Descendant · cites it directly · 102 of its ownK013392 Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate…Medtronic Vascular · 2002 · Recalled
  3. Descendant · 2 generations on · 61 of its ownK013873 Cobra Cardiac Electrosurgical SystemBoston Scientific Corp · 2002
  4. Descendant · 3 generations on · 46 of its ownK023288 Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies · 2003
  5. Descendant · cites it directly · 43 of its ownK021010 Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSEEndocare, Inc. · 2002
  6. Descendant · cites it directly · 42 of its ownK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004

Showing 5 of 104 descendants. See all descendants

Descendants cleared per year

2002: 32003: 32004: 42005: 22006: 132007: 52008: 102009: 42010: 42011: 42012: 72013: 32014: 52015: 12016: 12017: 12018: 52019: 82020: 22021: 22022: 32023: 22024: 62025: 22026: 4
2002high 13 (2006) · low 1 (2015)2026

Most influential descendants

Showing 5 of 104 · See all
  • K013392Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…Medtronic Vascular · 2002 · cites it directly102descendants
  • K013873Cobra Cardiac Electrosurgical SystemBoston Scientific Corp · 2002 · 2 generations on61descendants
  • K023288Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies · 2003 · 3 generations on46descendants
  • K021010Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSEEndocare, Inc. · 2002 · cites it directly43descendants
  • K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004 · cites it directly42descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011040Cryocare Cardiac Surgical SystemEndocare, Inc.2001—
+1K013392Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…Medtronic Vascular20021
+2K013873Cobra Cardiac Electrosurgical SystemBoston Scientific Corp2002—
+3K023288Cobra Bipolar Clamp, Model 15902Boston Scientific EP Technologies2003—
+1K021010Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSEEndocare, Inc.2002—
+1K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200330
200440
200520
2006130
200750
2008100
200940
201040
201140
201270
201330
201450
201510
201610
201710
201850
201980
202020
202120
202230
202320
202460
202520
202640
FIG. 1 — Lineage of K011040, 2001–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OCL? 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?

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

What descends from it? (104)

See all 104

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

NumberDeviceApplicantDecidedDescendants
K013392Cardioblate Surgical Ablation Pen, Model 60811C; Cardioblate Surgical Ablation…Medtronic Vascular2002102
K021010Modified Cardiac Cryosurgical System, Models 6TCS1 & 6TCSEEndocare, Inc.200243
K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc.200442
K053436Surgifrost 6CM, 7CM and 10 CM Cryosurgical Devices Plus Frostbyte Clamp and Cryosurgical…Cryocath Technologies, Inc.200622
K062140Surgifrost XL Cryosurgical Device, Model 60SFXL; Cryosurgical Console, Model 65CS1Cryocath Technologies, Inc.20061

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?

  • Of its descendants, K013392 (Medtronic Vascular, 2002) has gone furthest, with 102 descendants of its own.

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—

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 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/K011040 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011040: Cryocare Cardiac Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011040

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026