Cleared Traditional

K220008 - Solex 7 Intravascular Heat Exchange Cat...

K220008 is an FDA 510(k) clearance for Solex 7 Intravascular Heat Exchange Cat..., 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 149-day FDA review.

K220008 · Zoll Circulation, Inc. · Neurology device

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Jun 2022

Decision

149d

Days

Class 2

Risk

K220008 is an FDA 510(k) clearance for the Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Ex.... 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 June 2, 2022 after a review of 149 days - within the typical 510(k) review window.

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 - K220008

510(k) Number	K220008 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received	January 04, 2022
Decision Date	June 02, 2022
Days to Decision	149 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

1d slower than avg

Panel avg: 148d · This submission: 149d

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 K220008.

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

K213031 · Zoll Circulation, Inc. · Dec 2021

FDA 510(k) Resources - Neurology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.