Cleared Traditional

K012512 - SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM

K012512 is an FDA 510(k) clearance for SETPOINT ENDOVASCULAR TEMPERATURE MANAG..., manufactured by Radiant Medical. The device is a Class 2 Neurology device with product code NCX cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K012512 · Radiant Medical · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
309d
Days
Class 2
Risk

K012512 is an FDA 510(k) clearance for the SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM. Classified as System, Hypothermia, Intravenous, Cooling (product code NCX), Class II - Special Controls.

Submitted by Radiant Medical (Redwood City, US). The FDA issued a Cleared decision on June 11, 2002 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K012512

510(k) Number K012512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2001
Decision Date June 11, 2002
Days to Decision 309 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
160d slower than avg
Panel avg: 149d · This submission: 309d
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.

K012512 · SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
Download PDF FDA Summary Radiant Medical