# K163530: PrisMax Control Unit

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: May 3, 2017 after 138 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.
0 of 6 devices in its family (counting itself) have 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 4.

## Most influential descendants
- K190910: PrisMax System Version 2 (2019), 2 descendants 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
- K193482: PrisMax System Version 3 (2020), 0 descendants of its own

## Indications for use
The PrisMax 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. All treatments administered via the PrisMax control unit must be prescribed by a physician.

Source page: https://510kreport.com/device/K163530
Methodology: https://510kreport.com/methodology