# K131516: Prismaflex System 7.10

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products, Inc.
- Decided: Jan 3, 2014 after 220 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K171671: Prismaflex System 8.10 (2018), 4 descendants of its own
- K163530: PrisMax Control Unit (2017), 4 descendants of its own
- 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

## Recalls of this device
- Jan 28, 2021 · Class II · Z-1279-2021: Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.
- Apr 7, 2020 · Class II · Z-2066-2020: Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
- Apr 24, 2018 · Class II · Z-1925-2018: Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics.
- Apr 24, 2018 · Class II · Z-1926-2018: Baxter Healthcare will be installing new firmware on all Prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics.

## 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/K131516
Methodology: https://510kreport.com/methodology