FDA Product Code MLW: Warmer, Peritoneal Dialysate
Leading manufacturers include Thermasolutions, LLC.
FDA 510(k) Cleared Warmer, Peritoneal Dialysate Devices (Product Code MLW)
About Product Code MLW - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code MLW since 1994, with 6 receiving FDA clearance (average review time: 211 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MLW have taken an average of 445 days to reach a decision - up from 164 days historically. Manufacturers should account for longer review timelines in current project planning.
MLW devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →