FRESENIUS OPTIFLUX 200NR— 510(k) K002277
Substantially EquivalentFresenius Medical Care North America
FDA 510(k) clearance K002277 for FRESENIUS OPTIFLUX 200NR, Substantially Equivalent on 2000-08-25. 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
- Special
- Location
- Lexington, 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 K002277
K-number listed on FDA's recall record- Z-1099-2014 — Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment.
- Z-1101-2014 — Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment.
- Z-1103-2014 — Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K002277.
Data sourced from openFDA. This site is unofficial and independent of the FDA.