# K080519: Prismaflex M150 Set

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products, Inc.
- Decided: Jun 13, 2008 after 109 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K910215 (1991). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041005: Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets, Gambro Renal Products (2004) Summary page 1.

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

## Recalls of this device
- Jan 6, 2026 · Class II · Z-1228-2026: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- Sep 14, 2022 · Class II · Z-0082-2023: Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body
- Jul 18, 2014 · Class II · Z-2203-2014: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.

## Indications for use
The Prismaflex M150 Set is indicated for use only with the Prismaflex Control Unit in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.

Source page: https://510kreport.com/device/K080519
Methodology: https://510kreport.com/methodology