# K110823: Prismaflex

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products, Inc.
- Decided: Jun 17, 2011 after 85 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: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K062090 (2006). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062090: Prisma System R03.10A, Gambro Renal Products (2006) Summary page 2.
- K072093: Prismaflex System, Version 3.20, Gambro (2008) Summary page 2.

## Most influential descendants
- K170790: SAM CRRT Unit, SAM Cassette CRRT (2017), 0 descendants of its own

## Recalls of this device
- Jan 28, 2021 · Class II · Z-1278-2021: 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.
- Feb 6, 2020 · Class II · Z-1829-2020: Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
- Feb 6, 2020 · Class II · Z-1832-2020: Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
- Feb 6, 2020 · Class II · Z-1833-2020: Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
- Feb 6, 2020 · Class II · Z-1828-2020: Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
- Feb 6, 2020 · Class II · Z-1830-2020: Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
- Feb 6, 2020 · Class II · Z-1831-2020: Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.
- Apr 24, 2018 · Class II · Z-1923-2018: 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.
- Feb 15, 2017 · Class II · Z-1280-2018: Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, for software

## 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/K110823
Methodology: https://510kreport.com/methodology