# K924437: Hemospal Kit B22 / Multiflow 60 Kit

- Pathway: 510(k) (Traditional)
- Applicant: C.G.H. Medical, Inc.
- Decided: Jun 27, 1994 after 664 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 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
- K980386: Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0), Multiflow 100 Kits B22 (B22,B22/B, & B22/0) (1999), 9 descendants of its own
- K032431: Prisma M60/M100 Sets (2003), 8 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

Source page: https://510kreport.com/device/K924437
Methodology: https://510kreport.com/methodology