Cleared Traditional

K141139 - SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER

K141139 is an FDA 510(k) clearance for SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER, manufactured by Zoll Circulation. The device is a Class 2 Neurology device with product code NCX cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K141139 · Zoll Circulation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
154d
Days
Class 2
Risk

K141139 is an FDA 510(k) clearance for the SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER. Classified as System, Hypothermia, Intravenous, Cooling (product code NCX), Class II - Special Controls.

Submitted by Zoll Circulation (San Jose, US). The FDA issued a Cleared decision on October 3, 2014 after a review of 154 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.5900 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K141139

510(k) Number K141139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2014
Decision Date October 03, 2014
Days to Decision 154 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 149d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NCX Device Classification - Class 2, Special Controls

Product Code NCX System, Hypothermia, Intravenous, Cooling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5900
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 Neurology devices follow this clearance model.

Regulatory Peers - NCX System, Hypothermia, Intravenous, Cooling

All 25
Devices cleared under the same product code (NCX) and FDA review panel - the closest regulatory comparables to K141139.
Hypocore
K153162 · Novocor Medical Systems, Inc. · May 2016
Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
K153226 · Zoll Circulation, Inc. · Mar 2016
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
K150046 · Zoll Circulation, Inc. · Oct 2015
COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593
K101987 · Zoll Circulation · Oct 2010
INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM
K080908 · Innercool Therapies, Inc.- A Delaware Corporation · Oct 2008
SOLEX CATHETER, MODEL SL2593
K081936 · Alsius Corp. · Aug 2008
K141139 · SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
Download PDF FDA Summary Zoll Circulation