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 Medivance, Inc., 3M Company and Hangzhou Tappa Medical Technology Co., Ltd..
FDA 510(k) Cleared System, Thermal Regulating Devices (Product Code DWJ)
About Product Code DWJ - Regulatory Context
510(k) Submission Activity
158 total 510(k) submissions under product code DWJ since 1976, with 158 receiving FDA clearance (average review time: 141 days).
Submission volume has declined in recent years - 5 submissions in the last 24 months compared to 10 in the prior period.
FDA Review Time
FDA review times for DWJ submissions have been consistent, averaging 151 days recently vs 140 days historically.
DWJ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →