FDA Product Code DWJ: System, Thermal Regulating
FDA product code DWJ covers thermal regulating systems used to control patient body temperature during surgery and critical care.
These devices use forced air, water circulating blankets, or intravascular cooling catheters to maintain, raise, or lower patient body temperature within therapeutic ranges. They are used in targeted temperature management after cardiac arrest, fever control in ICU patients, and prevention of hypothermia during surgery.
DWJ devices are Class II medical devices, regulated under 21 CFR 870.5900 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include 3M Company, Medline Industries, LP and Molnlycke Health Care Us, LLC.
List of System, Thermal Regulating devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for System, Thermal Regulating devices (product code DWJ). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →