# K041005: Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets

- Pathway: 510(k) (Abbreviated)
- Applicant: Gambro Renal Products
- Decided: Oct 7, 2004 after 171 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: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K910215 (1991). 25 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 30 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021615: Baxter Accura System, Model 5M5660, Baxter Healthcare Corp (2002) Summary page 4.
- K963440: Dialog Dialysis Machine, B. Braun Medical AG (1998) Summary page 4.
- K010805: Prisma System, Gambro Renal Products (2002) Summary page 4.
- K032431: Prisma M60/M100 Sets, Gambro, Inc. (2003) Summary page 4.

## Most influential descendants
- 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
- Jan 6, 2026 · Class II · Z-1227-2026: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- Sep 14, 2022 · Class II · Z-0081-2023: 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 22, 2021 · Class II · Z-2378-2021: Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirmed Steril Milano observed nonconformances that were not reported to Baxter. Data was manipulated to appe
- Jul 18, 2014 · Class II · Z-2202-2014: 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-2201-2014: Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
- Jan 4, 2007 · Not classified · Z-0695-2007: Under certain conditions, * an excessive amount of anticoagulant may be infused into the patient. (* interruption of a self-test by an alarm and obstruction of the access lines)
- May 16, 2006 · Not classified · Z-0032-2007: A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.

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

Source page: https://510kreport.com/device/K041005
Methodology: https://510kreport.com/methodology