# K873155: Gambro Bicart System

- Pathway: 510(k) (Traditional)
- Applicant: Gambro, Inc.
- Decided: Oct 26, 1987 after 77 days
- Product code: FKP (System, Dialysate Delivery, Single Patient)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 3 cite it directly.
3 of 24 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
- K013724: Bicart (2002), 21 descendants of its own
- K101715: Fresenius 2008T Hemodialysis Machine Model 190573 (2010), 15 descendants of its own
- K120017: Fresenius 2008 Hemodiaysis Machine with Bibag System (2012), 14 descendants of its own
- K121341: Fresenius 2008T Hemodialysis Machine with Bibag System (2012), 13 descendants of its own
- K124035: 2008K@Home Hemodialysis Machine (2013), 11 descendants of its own

Source page: https://510kreport.com/device/K873155
Methodology: https://510kreport.com/methodology