# K850569: BSM 2000 Dialysis Machine - Modified

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Mar 12, 1985 after 28 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.
6 later devices descend from it; 1 cites it directly.
1 of 7 devices in its family (counting itself) has 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
- K963440: Dialog Dialysis Machine (1998), 5 descendants of its own
- K041005: Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets (2004), 4 descendants of its own
- K080519: Prismaflex M150 Set (2008), 1 descendant of its own
- K042938: Gambro Prismaflex HF1000 and HF1400 Sets (2005), 1 descendant of its own
- K220281: multiFiltratePRO System (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K850569
Methodology: https://510kreport.com/methodology