FRESENIUS 2008T HEMODIALYSIS MACHINE— 510(k) K120505
Substantially EquivalentFresenius Medical Care North America, Design Cente
FDA 510(k) clearance K120505 for FRESENIUS 2008T HEMODIALYSIS MACHINE, Substantially Equivalent on 2012-03-06. Applicant: Fresenius Medical Care North America, Design Cente. Device class: 2.
Clearance details
- Applicant
- Fresenius Medical Care North America, Design Cente
- 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
- Waltham, MA, US
Recent devices under product code KDI
view allMore clearances from Fresenius Medical Care North America, Design Cente
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 K120505
K-number listed on FDA's recall record- Z-0829-2018 — 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
- Z-1325-2016 — Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008¿ Series Machines are indicated for acute and chronic dialysis therapy
- Z-1550-2015 — 2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
- Z-1693-2013 — Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120505.
Data sourced from openFDA. This site is unofficial and independent of the FDA.