# K212216: Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Apr 1, 2022 after 259 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: 7 generations back to K910215 (1991). 31 ancestors in all.
No later device cites it as a predicate yet.
1 of 32 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 4.
- K080519: Prismaflex M150 Set, Gambro Renal Products, Inc. (2008) Summary page 5.
- K190910: PrisMax System Version 2, Baxter Healthcare Corp (2019) Summary page 5.

## Recalls of this device
- Jan 6, 2026 · Class II · Z-1225-2026: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- Jan 6, 2026 · Class II · Z-1224-2026: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- Sep 14, 2022 · Class II · Z-0084-2023: 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

## Indications for use
The Prismaflex ST set is a single use device that provides blood purification through a semipermeable membrane. The Prismaflex ST set is for use only in conjunction with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered). All treatments administered via the PrismaFlex ST sets must be prescribed by a physician. The size, weight, state of uremia, cardiac status, and general physical condition of the patient must be carefully evaluated by the prescribing physician before each treatment. If patients suffer from acute kidney injury and / or volume overload, the Prismaflex ST set is indicated for continuous renal replacement therapies (CRRT), in modalities such as: • Slow Continuous UltraFiltration (SCUF) • Continuous Veno-Venous Hemofiltration (CVVH) • Continuous Veno-Venous HemoDialysis (CVVHD) • Continuous Veno-Venous HemoDiaFiltration (CVVHDF) to perform fluid management and reduction of uremic toxins. The Prismaflex ST100 and ST150 set is indicated for use in patients with a body weight equal or greater than 30 kg (66lb) and Prismaflex ST60 set is indicated to patients with a body weight greater than 11kg (24lb).

Source page: https://510kreport.com/device/K212216
Methodology: https://510kreport.com/methodology