510(k) K212216 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set
| Applicant | Baxter Healthcare Corporation, Deerfield Lake IL, US |
| Decision | Substantially Equivalent, Apr 1, 2022 |
| Received | Jul 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212216
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2026 | VANTIVE US HEALTHCARE LLC PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System Open, Classified |
KDI | None listed |
| Feb 2, 2026 | VANTIVE US HEALTHCARE LLC PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System Open, Classified |
KDI | None listed |
| Oct 12, 2022 | Baxter Healthcare Corporation Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid management and renal replacement therapies. Open, Classified |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.