Company ยท US
Fresenius Medical Care North America
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2025. Name variants (Inc, Corp, punctuation) are merged.
43510(k) clearances (0 in 12 months)
12recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 22 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 5 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 4 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 4 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 4 |
| FKP | System, Dialysate Delivery, Single Patient | 3 |
| FKX | System, Peritoneal, Automatic Delivery | 3 |
| FIB | Protector, Transducer, Dialysis | 2 |
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | 2 |
| ONW | Hemodialysis System For Home Use | 2 |
| FIP | Subsystem, Water Purification | 1 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| MSE | Hemodialyzer, Re-Use, Low Flux | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 9, 2025 | K252181 | AquaA Fresenius Medical Care North America | FIP |
| Apr 6, 2017 | K162488 | Optiflux dialyzer Fresenius Medical Care North America | KDI |
| Nov 5, 2015 | K152953 | CRIT-LINE CLIP (CLIC) BLOOD CHAMBER Fresenius Medical Care North America | KOC |
| Oct 29, 2015 | K152367 | Optiflux dialyzer Fresenius Medical Care North America | KDI |
| Jan 6, 2014 | K123262 | OPTIFLUX ULTRA DIALYZER Fresenius Medical Care North America | KDI |
| Aug 29, 2013 | K131611 | FRESENIUS DRY ACID DISSOLUTION UNITS Fresenius Medical Care North America | KPO |
| Jul 3, 2013 | K124035 | 2008K@HOME HEMODIALYSIS MACHINE Fresenius Medical Care North America | ONW |
| Dec 6, 2012 | K121341 | FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM Fresenius Medical Care North America | KDI |
| Nov 9, 2012 | K121599 | CRIT-LINE CLIP (CLIC) Fresenius Medical Care-North America | KOC |
| Feb 2, 2012 | K120017 | FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM Fresenius Medical Care North America | KDI |
| Dec 21, 2011 | K113427 | FRESENIUS 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America | KDI |
| Feb 3, 2011 | K070049 | FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR Fresenius Medical Care North America | ONW |
| May 27, 2010 | K093902 | MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 Fresenius Medical Care North America | KDI |
| Jan 14, 2009 | K080964 | FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America | KDI |
| Dec 29, 2008 | K083542 | FRESENIUS STERILE STAY SAFE CAP Fresenius Medical Care North America | KDJ |
| Oct 28, 2008 | K082414 | OPTIFLUX F250NR, MODEL 0500325E Fresenius Medical Care North America | KDI |
| Jun 15, 2007 | K071387 | FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB Fresenius Medical Care North America | KPO |
| Apr 24, 2007 | K070222 | FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N Fresenius Medical Care North America | KDI |
| Mar 29, 2007 | K070177 | FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES Fresenius Medical Care North America | KPO |
| Sep 5, 2006 | K060734 | FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) Fresenius Medical Care North America | LKN |
| Jun 8, 2005 | K050273 | FRESENIUS ART HEMOADSORPTION SYSTEM Fresenius Medical Care North America | LKN |
| Mar 31, 2005 | K043363 | FRESENIUS LIBERTY CYCLER Fresenius Medical Care North America | FKX |
| Dec 20, 2004 | K043244 | FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR Fresenius Medical Care North America | KDI |
| Sep 24, 2004 | K041792 | FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 Fresenius Medical Care North America | KDJ |
| Jul 16, 2004 | K041042 | SPLIT SEPTUM INJECTION SITES Fresenius Medical Care North America | FPA |
| Jan 30, 2004 | K034064 | FRESENIUS ULTRAFLO HPX HEMODIALYZER Fresenius Medical Care North America | KDI |
| May 30, 2003 | K031378 | FRESENIUS ULTRAFLUX HEMODIALYZER Fresenius Medical Care North America | KDI |
| Mar 5, 2003 | K022412 | FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR Fresenius Medical Care North America | KDJ |
| Nov 13, 2002 | K021060 | FRESENIUS ICARE MONITORING SYSTEM Fresenius Medical Care North America | FKP |
| Aug 16, 2001 | K012242 | FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS Fresenius Medical Care North America | FJK |
| Apr 27, 2001 | K010268 | FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9 Fresenius Medical Care North America | KOC |
| Apr 5, 2001 | K002892 | FRSENIUS PD IQCARD CYCLER Fresenius Medical Care North America | FKX |
| Jan 4, 2001 | K003498 | FRESENIUS OPTIFLUX 200A Fresenius Medical Care North America | KDI |
| Dec 4, 2000 | K002761 | FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS Fresenius Medical Care North America | FJI |
| Dec 1, 2000 | K003445 | FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 Fresenius Medical Care North America | FIB |
| Aug 25, 2000 | K002277 | FRESENIUS OPTIFLUX 200NR Fresenius Medical Care North America | KDI |
| Jul 28, 2000 | K001873 | HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0 Fresenius Medical Care North America | FJK |
| Jun 23, 2000 | K001107 | FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) Fresenius Medical Care North America | FJK |
| Jun 7, 2000 | K000702 | BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR Fresenius Medical Care North America | FIB |
| May 9, 2000 | K000451 | FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290 Fresenius Medical Care North America | FJK |
| Sep 3, 1999 | K982926 | FRESENIUS BLOOD VOLUME MONITOR Fresenius Medical Care North America | KDI |
| Jul 30, 1999 | K991520 | FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION Fresenius Medical Care North America | KDI |
| Aug 27, 1998 | K974090 | 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS Fresenius Medical Care North America | MSE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 15, 2010 | Fresenius Medical Care North America Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA Terminated |
FKP | K921456 |
| Aug 15, 2010 | Fresenius Medical Care North America Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank, Model Numbers G047-80101 and RTLG047-80101, Manufactured by Fresenius USA Inc., Walnut Creek, CA Terminated |
KPO | K911459 |
| Aug 15, 2010 | Fresenius Medical Care North America Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Manufactured by Fresenius USA Inc., Walnut Creek, CA Terminated |
KDI | K994267 |
| Aug 15, 2010 | Fresenius Medical Care North America Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA Terminated |
FKP | K921456 |
| Jul 1, 2010 | Fresenius Medical Care North America Optiflux F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 84404.
Designed for single use acute and chronic hemodialysis. Terminated |
KDI | K002277 |
| Jan 23, 2009 | Fresenius Medical Care North America CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister)
Product Code: 03-2794-0
Bonded CombiSets - includes pri Terminated |
KOC | K022536 |
| Jan 23, 2009 | Fresenius Medical Care North America CombiSet True Flow Series, Hemodialysis Blood Tubing with Priming Set and Transducer Protectors, with Access Flow Reversing Connector (Twister)
Product Code: 03-2994-6 24 sets / case
CombiSet Bloodl Terminated |
KOC | K022536 |
| Feb 1, 2008 | Fresenius Medical Care North America Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer) Terminated |
KDI | K002277 |
| May 3, 2006 | Fresenius Medical Care North America Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis.
Catalog Number: 050-87028 Terminated |
FKX | K002892 |
| Dec 31, 2005 | Fresenius Medical Care North America Optiflux Series Fresenius Polysulfone F180NR dialyzer High Flux
Catalog Number: 0500318N Terminated |
KDI | None listed |
| Dec 31, 2005 | Fresenius Medical Care North America Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux
Catalog Number: 0500316N Terminated |
KDI | K002277 |
| Oct 13, 2004 | Fresenius Medical Care North America Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile
with Female Safe Lock Connector Luer Lock and Slide Clamp
Catalog Number: 050-30034 Terminated |
KDJ | K822550 |