510(k) K243920

Purema H Hemoconcentrator - Pediatric by Medica USA, Inc. — Product Code KDI

K243920 is an FDA 510(k) premarket notification submitted by Medica USA, Inc. for the device "Purema H Hemoconcentrator - Pediatric". The FDA issued a decision of Substantially Equivalent on September 19, 2025. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860.