# K013724: Bicart

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products
- Decided: Jan 8, 2002 after 60 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- 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
Longest line of descent: 1 generation back to K873155 (1987). 2 ancestors in all.
21 later devices descend from it; 5 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)
- K873155: Gambro Bicart System, Gambro, Inc. (1987) Summary page 2.
- K940601: Gambro Bicart 720G, C.G.H. Medical, Inc. (1994) Summary page 2.

## Most influential descendants
- 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
- K131908: 2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic) (2013), 10 descendants of its own

## Indications for use
Gambro BiCart® is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.

Source page: https://510kreport.com/device/K013724
Methodology: https://510kreport.com/methodology