# K243920: Purema H Hemoconcentrator - Pediatric

- Pathway: 510(k) (Traditional)
- Applicant: Medica USA, Inc.
- Decided: Sep 19, 2025 after 273 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923139 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973516: Capiox Hemoconcentrator, Terumo Medical Corp. (1998) Summary page 7.

## Indications for use
The Purema® H Hemoconcentrator - Pediatric is designed to remove excess fluid from the blood in order to maintain proper hematocrit and protein concentration during cardiopulmonary bypass and to enable reinfusion of blood remaining in the circuit after bypass. It is intended to be used in a hospital setting, in connection with a suitable circuit for extracorporeal blood circulation and a pump that regulates its flow. There are no other accessories. The Purema® H Hemoconcentrator - Pediatric model DP03HC is intended to be used for pediatric patients.

Source page: https://510kreport.com/device/K243920
Methodology: https://510kreport.com/methodology