# K852698: Bio Medicus Bio Pump Model BP-80

- Pathway: 510(k) (Traditional)
- Applicant: Bio Medicus, Inc.
- Decided: Sep 30, 1985 after 96 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
66 later devices descend from it; 4 cite it directly.
4 of 67 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
- K973011: BPX80 Bio-Pump (BPX80) (1998), 48 descendants of its own
- K020271: Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100 (2003), 21 descendants of its own
- K991783: AB-180 XC System, Model AB-180XC (2000), 13 descendants of its own
- K011835: Cobe Revolution (2002), 12 descendants of its own
- K053630: Levitronix Centrimag Primary Console (2006), 11 descendants of its own

Source page: https://510kreport.com/device/K852698
Methodology: https://510kreport.com/methodology