# K042938: Gambro Prismaflex HF1000 and HF1400 Sets

- Pathway: 510(k) (Special)
- Applicant: Gambro Renal Products
- Decided: Jan 6, 2005 after 73 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: 6 generations back to K910215 (1991). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 29 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011221: Prisma HF 1000 Set, Prisma HF 1000 Pre-Set, Gambro Renal Products (2001) Summary page 1.
- K041005: Gambro Prismaflex and Gambro Prismaflex M60 & M100 Sets, Gambro Renal Products (2004) Summary page 1.

## Most influential descendants
- K220281: multiFiltratePRO System (2022), 0 descendants of its own

## Recalls of this device
- Jan 6, 2026 · Class II · Z-1229-2026: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- Jan 6, 2026 · Class II · Z-1230-2026: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- Sep 14, 2022 · Class II · Z-0083-2023: 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
- Sep 14, 2022 · Class II · Z-0085-2023: 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-2379-2021: 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 appear 
- Jul 18, 2014 · Class II · Z-2204-2014: 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-2205-2014: 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 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/K042938
Methodology: https://510kreport.com/methodology