Cleared Traditional

K011040 - CRYOCARE CARDIAC SURGICAL SYSTEM

K011040 is an FDA 510(k) clearance for CRYOCARE CARDIAC SURGICAL SYSTEM, manufactured by Endocare, Inc.. The device is a Class 2 Cardiovascular device with product code OCL cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K011040 · Endocare, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
71d
Days
Class 2
Risk

K011040 is an FDA 510(k) clearance for the CRYOCARE CARDIAC SURGICAL SYSTEM. Classified as Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (product code OCL), Class II - Special Controls.

Submitted by Endocare, Inc. (Irvine, US). The FDA issued a Cleared decision on June 15, 2001 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4400 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Endocare, Inc. devices

FDA 510(k) Submission Details - K011040

510(k) Number K011040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2001
Decision Date June 15, 2001
Days to Decision 71 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OCL Device Classification - Class 2, Special Controls

Product Code OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

All 50
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K011040.
CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12
K041890 · Cryocor, Inc. · Sep 2004
MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
K021010 · Endocare, Inc. · Jun 2002
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C
K013392 · Medtronic Vascular · Jan 2002
CRYOGEN CARDIAC CRYOSURGICAL SYSTEM
K974320 · Cryogen, Inc. · Feb 1998
HEARTPORT MAZE SYSTEM: CRYOPROBE SET
K970496 · Heartport, Inc. · May 1997