# K973322: Diapact CRRT

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Nov 10, 1998 after 432 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
Longest line of descent: 1 generation back to K900105 (1991). 2 ancestors in all.
39 later devices descend from it; 3 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900105: Cobe Spectra Blood Component Separator Therapeutic, Cobe Laboratories, Inc. (1991) Summary page 1.
- K946279: Prisma CFM (Continuous Fluid Management System), Cobe Renal Care, Inc. (1997) Summary page 1.

## Most influential descendants
- K030470: Nxstage System One (2003), 29 descendants of its own
- K041424: Nxstage System One (2004), 28 descendants of its own
- K050525: Nxstage System One (2005), 27 descendants of its own
- K062079: Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210 (2006), 26 descendants of its own
- K083778: Xenium XPH, Models 110, 130, 150, 170, 190 and 210 (2009), 20 descendants of its own

## Indications for use
It is an extracorporeal blood purification system intended to be used for acute renal failure. The system provides high flow continuous renal replacement therapies, emergency intermittent dialysis treatment and plasmapheresis.

Source page: https://510kreport.com/device/K973322
Methodology: https://510kreport.com/methodology