Cleared Traditional

K150046 - Start-Up Kit (SUK)

K150046 is an FDA 510(k) clearance for Start-Up Kit (SUK), manufactured by Zoll Circulation, Inc.. The device is a Class 2 Neurology device with product code NCX cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K150046 · Zoll Circulation, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
291d
Days
Class 2
Risk

K150046 is an FDA 510(k) clearance for the Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intra.... Classified as System, Hypothermia, Intravenous, Cooling (product code NCX), Class II - Special Controls.

Submitted by Zoll Circulation, Inc. (San Jose, US). The FDA issued a Cleared decision on October 30, 2015 after a review of 291 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.

View all Zoll Circulation, Inc. devices

FDA 510(k) Submission Details - K150046

510(k) Number K150046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received January 12, 2015
Decision Date October 30, 2015
Days to Decision 291 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 148d · This submission: 291d
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

Devices cleared under the same product code (NCX) and FDA review panel - the closest regulatory comparables to K150046.
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
K223746 · Zoll Circulation, Inc. · Jan 2023
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
K220008 · Zoll Circulation, Inc. · Jun 2022
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console
K213031 · Zoll Circulation, Inc. · Dec 2021