# PrisMax System Version 2

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/prismax-system-version-2-kdi>
- Manufacturer: [Baxter Healthcare Corp](https://devicerts.com/manufacturers/baxter-healthcare-corp) (United States, FDA 510(k) applicant)
- Device class: Class II (US FDA)
- FDA product code: KDI

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K190910 · decision 2019-07-25 · decision SESE · status: Active

## Recalls

- Z-2437-2025 · Class II · ongoing · initiated 2025-07-28: 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
- Z-2439-2025 · Class II · ongoing · initiated 2025-07-28: 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
- Z-0215-2022 · Class II · ongoing · initiated 2021-09-29: 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 from the original prescription profile, rather than the current prescription.
- Z-1151-2021 · Class II · terminated · initiated 2021-01-07: 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 replaced during annual preventative maintenance. Alarm Situations: During System Self-Test: Alarm code B1215 (ARPS Self-Test failure); During Therapy: B1273 (ARPS Leak), B1215 (ARPS Pressure self-test), B1116 (Return Pressure self-test Failure), B1539 (Access Pod Reposition Failure), B1541 (Effluent Pod Reposition Failure), B1540 (Effluent Filter Pod Reposition Failure). If an alarm occurs, it may lead to delay or interruption of therapy. In the event that therapy is terminated without returning blood to the patient, blood loss may occur.
- Z-0247-2020 · Class II · terminated · initiated 2019-09-19: 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.

## Identifiers

- 510(k) Number: K190910 [FDA 510(k)]
- FDA product code: KDI [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 876.5860 [FDA 510(k)]
- Advisory committee: Gastroenterology, Urology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: PrisMax System Version 2, Baxter Healthcare Corp. deviCERTS medical device catalogue. https://devicerts.com/devices/prismax-system-version-2-kdi (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/prismax-system-version-2-kdi.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/prismax-system-version-2-kdi
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.