Cleared Traditional

K081936 - SOLEX CATHETER, MODEL SL2593

K081936 is an FDA 510(k) clearance for SOLEX CATHETER, manufactured by Alsius Corp.. The device is a Class 2 Neurology device with product code NCX cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K081936 · Alsius Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
37d
Days
Class 2
Risk

K081936 is an FDA 510(k) clearance for the SOLEX CATHETER, MODEL SL2593. Classified as System, Hypothermia, Intravenous, Cooling (product code NCX), Class II - Special Controls.

Submitted by Alsius Corp. (Irvine, US). The FDA issued a Cleared decision on August 13, 2008 after a review of 37 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K081936

510(k) Number K081936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2008
Decision Date August 13, 2008
Days to Decision 37 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
112d faster than avg
Panel avg: 149d · This submission: 37d
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 K081936.
SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
K141139 · Zoll Circulation · Oct 2014
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
ARCTIC BLAST INTRAVENOUS FLUID CHILLER
K080899 · Medivance, Inc. · Aug 2008
THERMOGARD XP THERMAL REGULATION SYSTEM
K072234 · Alsius Corp. · Aug 2007
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
K071358 · Radiant Medical · Jun 2007
K081936 · SOLEX CATHETER, MODEL SL2593
Download PDF FDA Summary Alsius Corp.