510(k) K162488 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Optiflux dialyzer
| Applicant | Fresenius Medical Care North America, Waltham MA, US |
| Decision | Substantially Equivalent, Apr 6, 2017 |
| Received | Sep 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162488
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 3, 2025 | Fresenius Medical Care Holdings, Inc. Optiflux High Flux E-beam Dialyzer
Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) Open, Classified |
FJI | None listed |
| Jan 3, 2025 | Fresenius Medical Care Holdings, Inc. Dialyzer Optiflux 160NRe Open, Classified |
KDI | None listed |
| May 4, 2022 | Fresenius Medical Care Holdings, Inc. Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E Terminated |
KDI | None listed |
| Nov 5, 2018 | Fresenius Medical Care Renal Therapies Group, LLC Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.