# K032431: Prisma M60/M100 Sets

- Pathway: 510(k) (Special)
- Applicant: Gambro, Inc.
- Decided: Sep 15, 2003 after 40 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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K924437 (1994). 4 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946279: Prisma CFM (Continuous Fluid Management System), Cobe Renal Care, Inc. (1997) Summary page 1.
- K981681: Prisma CFM (Continuous Fluid Management System), Gambro Healthcare (1998) Summary page 1.
- K980386: Hospal Multiflow 100, Multiflow 100 Kits A0 (A0,A0/B and A0/0), Multiflow 100 Kits B22 (B22,B22/B, & B22/0), Gambro Healthcare (1999) Summary page 1.

## Most influential descendants
- 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
- K212216: Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set (2022), 0 descendants of its own

## Recalls of this device
- Jul 18, 2014 · Class II · Z-2195-2014: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
- Jul 18, 2014 · Class II · Z-2199-2014: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
- Jul 18, 2014 · Class II · Z-2198-2014: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
- Jul 18, 2014 · Class II · Z-2197-2014: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
- Jul 18, 2014 · Class II · Z-2196-2014: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
- Oct 24, 2005 · Not classified · Z-0705-06: After dialysis machine is disconnected from the patient, blood leakage may occur while unloading the tubing sets from the machine.

## Indications for use
Indicated for use with the Prisma Control Unit in providing continuous fluid management and renal replacement therapies for patients who have acute renal failure, fluid overload, or both.

Source page: https://510kreport.com/device/K032431
Methodology: https://510kreport.com/methodology