510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162523Substantially Equivalent

The IQool System

Braincool AB, Medicon Village, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162523 is the FDA 510(k) clearance record for The IQool System, a class II device, cleared for Braincool AB on under FDA product code NZE (Hyperthermia Monitor). FDA's definition for product code NZE reads: "Intended to monitor and reduce a patient's temperature to mild hypothermia (not to go below 32 degrees celsius. To induce mild hypothermia in hyperthermic patients e.g., heat stroke, fever (excluding fever related to head injury, cardiac...". FDA records list 4 510(k) clearances for Braincool AB, from to . As of , FDA records show no recalls naming K162523.

Clearance record

Decision date
Received
(236 days to decision)
Product code
NZE Hyperthermia Monitor
Regulation
21 CFR 870.5900
Device class
Class II
Review panel
Cardiovascular
Applicant
Braincool AB Scheelevagen 2, Medicon Village, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NZE

Trailing 12 months

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

FDA records show no clearances under product code NZE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NZE, 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