510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012512Substantially Equivalent

Setpoint Endovascular Temperature Management System

Radiant Medical, Redwood City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012512 is the FDA 510(k) clearance record for SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM, a class II device, cleared for Radiant Medical on under FDA product code NCX (System, Hypothermia, Intravenous, Cooling). FDA records list 6 510(k) clearances for Radiant Medical, from to . As of , FDA records show no recalls naming K012512.

Clearance record

Decision date
Received
(309 days to decision)
Product code
NCX System, Hypothermia, Intravenous, Cooling
Regulation
21 CFR 870.5900
Device class
Class II
Review panel
Cardiovascular
Applicant
Radiant Medical 250 Chesapeake Dr., Redwood City CA
510(k) summary
Summary
Third party review
No

Clearances, product code NCX

Trailing 12 months

FDA records hold no clearances under product code NCX in the trailing twelve months.

FDA records show no clearances under product code NCX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NCX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260