# K072093: Prismaflex System, Version 3.20

- Pathway: 510(k) (Traditional)
- Applicant: Gambro
- Decided: Feb 1, 2008 after 186 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: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“14143”).
- (no number) Prismaflex® System 1.04: named in the summary without a submission number

## Most influential descendants
- K110823: Prismaflex (2011), 1 descendant of its own
- K170790: SAM CRRT Unit, SAM Cassette CRRT (2017), 0 descendants of its own

## Recalls of this device
- Jan 28, 2021 · Class II · Z-1277-2021: 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.
- Oct 4, 2019 · Class II · Z-0277-2020: Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
- Oct 4, 2019 · Class II · Z-0276-2020: Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
- Oct 4, 2019 · Class II · Z-0278-2020: Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
- Oct 4, 2019 · Class II · Z-0279-2020: Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
- Oct 4, 2019 · Class II · Z-0280-2020: Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
- Apr 24, 2018 · Class II · Z-1922-2018: 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.
- Mar 14, 2011 · Not classified · Z-1901-2011: Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure.

## Indications for use
The Prismaflex® System is intended for Continuous Renal Replacement Therapy (CRRT) for patients with acute renal failure and/or fluid overload weighing 20 Kilograms or more. All treatments administered via the Prismaflex® must be prescribed via a physician.

Source page: https://510kreport.com/device/K072093
Methodology: https://510kreport.com/methodology