Optiflux dialyzer— 510(k) K162488
Substantially EquivalentFresenius Medical Care North America
FDA 510(k) clearance K162488 for Optiflux dialyzer, Substantially Equivalent on 2017-04-06. Applicant: Fresenius Medical Care North America. Device class: 2.
Clearance details
- Applicant
- Fresenius Medical Care North America
- Product code
- Code KDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5860
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Recent devices under product code KDI
view allMore clearances from Fresenius Medical Care North America
view allAdverse events under product code KDI
product code KDI- Death
- 352
- Injury
- 1,474
- Malfunction
- 12,534
- Other
- 4
- Total
- 14,364
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K162488
K-number listed on FDA's recall record- Z-0041-2026 — 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) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
- Z-0801-2025 — Dialyzer Optiflux 160NRe
- Z-1303-2022 — Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
- Z-0658-2019 — Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162488.
Data sourced from openFDA. This site is unofficial and independent of the FDA.