# K973516: Capiox Hemoconcentrator

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Jan 30, 1998 after 135 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: 1 generation back to K923139 (1994). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923139: Hemocor HP Hemoconcentrator Series, Minntech Corp. (1994) Summary page 2.

## Most influential descendants
- K243920: Purema H Hemoconcentrator - Pediatric (2025), 0 descendants of its own
- K232171: Purema® H Hemoconcentrator (EtO Sterilized) (2024), 0 descendants of its own

## Indications for use
The CAPIOX Hemoconcentrator 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 during and after surgical procedures requiring cardiopulmonary bypass (up to 6 hours) when the removal of excess fluid from blood is required. It should not be used as a dialyzer, hemofilter or other device.

Source page: https://510kreport.com/device/K973516
Methodology: https://510kreport.com/methodology