# K891230: Maxima* Hollow Fiber Oxygenator W/Filtered Reserv.

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Blood Systems, Inc.
- Decided: May 19, 1989 after 73 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961836: Maxima Forte Hardshell Venous Reservoir (1996), 1 descendant of its own
- K980935: Capiox SX Hardshell Reservoir (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K891230
Methodology: https://510kreport.com/methodology