DeviceClearance

Product code NZE— Cardiovascular

CarbonCool® System

Classification name
Hyperthermia Monitor
Device class
Class 2
Regulation
21 CFR 870.5900
Advisory panel
Cardiovascular
Total cleared
6
First cleared
Most recent

FDA classification definition

“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 arrest, or other severe medical conditions).”

— U.S. Food and Drug Administration, device classification record for product code NZE under 21 CFR 870.5900, via openFDA

Market context for product code NZE

FDA has cleared 6 devices under product code NZE between 2006 and 2025, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NZE

Recent clearances under product code NZE

Data sourced from openFDA. This site is unofficial and independent of the FDA.