DeviceClearance

Product code MLW— Gastroenterology, Urology

DAYTRIPPER DIALYSATE WARMER

Classification name
Warmer, Peritoneal Dialysate
Device class
Class 2
Regulation
21 CFR 876.5630
Advisory panel
Gastroenterology, Urology
Total cleared
6
First cleared
Most recent

Market context for product code MLW

FDA has cleared 6 devices under product code MLW between 1994 and 2025, filed by 6 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 MLW

Recent clearances under product code MLW

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