510(k) K190910 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PrisMax System Version 2
| Applicant | Baxter Healthcare Corp, Brooklyn Park Mn MN, US |
| Decision | Substantially Equivalent, Jul 25, 2019 |
| Received | Apr 8, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190910
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2025 | VANTIVE US HEALTHCARE LLC PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701 Open, Classified |
KDI | None listed |
| Aug 26, 2025 | VANTIVE US HEALTHCARE LLC TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631 Open, Classified |
KDI | None listed |
| Sep 29, 2021 | Baxter Healthcare Corporation Hemodialysis Delivery System, Software Version 2.x. Open, Classified |
KDI | None listed |
| Jan 7, 2021 | Baxter Healthcare Corporation The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers:
a) 955626
b) 955558
c) 955701
PrisMax V2 Preventive Maint Terminated |
KDI | None listed |
| Oct 30, 2019 | Baxter Healthcare Corporation TherMax Blood Warmer Unit Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.