PrisMax System Version 2
510(k) K190910
PrisMax System Version 2 is a medical device (FDA Class II; FDA product code KDI, Dialyzer, High Permeability With Or Without Sealed Dialysate System) made by Baxter Healthcare Corp, cleared under FDA 510(k) K190910 on 25 Jul 2019, active as of 22 Oct 2026. 5 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
3 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK190910 | Date25 Jul 2019 | StatusActive |
Official records
- FDA 510(k) database K190910
Recalls
-
- Ongoing 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
-
- Ongoing 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
-
- Ongoing 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 from the original prescription profile, rather than the current prescription.
-
- Terminated 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 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.
-
- Terminated 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.
Timeline
- Cleared FDA 510(k) K190910
- Recall initiated FDA recalls Z-0247-2020
- Recall initiated FDA recalls Z-1151-2021
- Recall initiated FDA recalls Z-0215-2022
- Recall initiated FDA recalls Z-2437-2025
- Recall initiated FDA recalls Z-2439-2025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KDI
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5860
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System).
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- PRISMA SYSTEM by Gambro Renal Products, Inc.
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- ALTRA NOVA 200 HEMODAILYZER by Althin Medical AB an Affiliate of Baxter Intl
- A-22 HEMODIALYZER by Althin Medical AB
- FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE by Fresenius Medical Care North America
- HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H by National Medical Care, Medical Products Div., Inc.