# K892664: Cardiopulmonary Support (CPS) System

- Pathway: 510(k) (Traditional)
- Applicant: Bard Cardiosurgery Div
- Decided: Feb 13, 1990 after 306 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.
6 later devices descend from it; 1 cites it directly.
2 of 7 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
- K090006: Lifebridge B2T, Model 7001 (2009), 5 descendants of its own
- K102726: Cardiohelp System (2011), 2 descendants of its own
- K133598: Cardiohelp System (2014), 0 descendants of its own
- K133265: Quadrox-IR Adult and Small Adult (2013), 0 descendants of its own
- K111384: Lifebridge (2011), 0 descendants of its own

Source page: https://510kreport.com/device/K892664
Methodology: https://510kreport.com/methodology