510(k) K042938 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
| Applicant | Gambro Renal Products, Lakewood CO, US |
| Decision | Substantially Equivalent, Jan 6, 2005 |
| Received | Oct 25, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042938
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2026 | VANTIVE US HEALTHCARE LLC PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System Open, Classified |
KDI | None listed |
| Feb 2, 2026 | VANTIVE US HEALTHCARE LLC PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System Open, Classified |
KDI | None listed |
| Oct 12, 2022 | Baxter Healthcare Corporation Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid management and renal replacement therapies. Open, Classified |
KDI | None listed |
| Oct 12, 2022 | Baxter Healthcare Corporation Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies. Open, Classified |
KDI | None listed |
| Jul 22, 2021 | Baxter Healthcare Corporation Baxter prismaflex, HF 1000 PAES membrane, REF 107140
Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies. Terminated |
KDI | None listed |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | None listed |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.