# K993064: Prisma CFM (Continuous Fluid Management System)

- Pathway: 510(k) (Special)
- Applicant: Gambro Renal Care Products
- Decided: Oct 6, 1999 after 23 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K910215 (1991). 10 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970253: Cobe Centrysystem 3 Dialysis Control Unit/Cobe Cartridge Blood Tubing Set, Gambro Healthcare (1997) Summary page 1.
- K982760: Cobe C Hemodialysis Delivery System , Cobe Cartridge Blood Tubing Set, Gambro Healthcare (1998) Summary page 1.
- K970446: Drake Willock System & Altra Touch 1000 Dialysis Delivery System, Althin Medical AB an Affiliate of Baxter Intl (1997) Summary page 1.

## Most influential descendants
- K021615: Baxter Accura System, Model 5M5660 (2002), 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
- K070320: Edwards Aquarius Hemofiltration System, Model Abm 01 (2007), 1 descendant of its own
- K042938: Gambro Prismaflex HF1000 and HF1400 Sets (2005), 1 descendant of its own

## Recalls of this device
- Aug 16, 2005 · Not classified · Z-1545-05: Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss.

## Indications for use
The PRISMA ™ System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. All treatments administered via the PRISMA System must be prescribed by a physician.

Source page: https://510kreport.com/device/K993064
Methodology: https://510kreport.com/methodology