# K171671: Prismaflex System 8.10

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Feb 23, 2018 after 262 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K131516 (2014). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131516: Prismaflex System 7.10, Gambro Renal Products, Inc. (2014) Summary page 5.

## Most influential descendants
- K190910: PrisMax System Version 2 (2019), 2 descendants of its own
- K212216: Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set (2022), 0 descendants of its own
- K193482: PrisMax System Version 3 (2020), 0 descendants of its own
- K192756: Aquadex FlexFlow System 2.0 (2020), 0 descendants of its own

## Indications for use
The Prismaflex control unit is intended for: • Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. • Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated. All treatments administered via the Prismaflex control unit must be prescribed by a physician.

Source page: https://510kreport.com/device/K171671
Methodology: https://510kreport.com/methodology