# K982467: Capiox Cardioplegia

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Jun 23, 1999 after 343 days
- Product code: DTR (Heat-Exchanger, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4240
- 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 K923311 (1992). 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)
- K934847: Ngbcd & Ngbcdp Cardioplegia Delivery Systems, Sorin Biomedical, Inc. (1994) Summary page 1.
- K923311: Conducer Heat Exchanger, 3M Health Care, Sarns (1992) Summary page 1.

## Indications for use
The CAPIOX Cardioplegia is cardiopulmonary bypass heat exchanger consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device for periods up to 6 hours.

Source page: https://510kreport.com/device/K982467
Methodology: https://510kreport.com/methodology