# K190910: PrisMax System Version 2

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jul 25, 2019 after 108 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K131516 (2014). 3 ancestors in all.
2 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)
- K171671: Prismaflex System 8.10, Baxter Healthcare Corporation (2018) Summary page 4.
- K163530: PrisMax Control Unit, Baxter Healthcare Corp (2017) Summary page 5.

## Most influential descendants
- 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

## Recalls of this device
- Jul 28, 2025 · Class II · Z-2437-2025: Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles
- Jul 28, 2025 · Class II · Z-2439-2025: Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted
- Sep 29, 2021 · Class II · Z-0215-2022: If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values
- Jan 7, 2021 · Class II · Z-1151-2021: Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-test and therapy. This tubing is normally 
- Sep 19, 2019 · Class II · Z-0247-2020: TherMax Blood Warmers may not be in compliance with an electrical safety standard, which requires a protective earth connection that can sustain a current of 25 amps for 10 seconds.

## 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. • 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 PrisMax control unit must be prescribed by a physician.

Source page: https://510kreport.com/device/K190910
Methodology: https://510kreport.com/methodology