Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Fresenius Medical Care North America · Predicate Candidate Screening

43 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

88 daysmedian FDA review time

285 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252181	AquaA	Fresenius Medical Care North America	2025-09-09	60	0
K162488	Optiflux dialyzer	Fresenius Medical Care North America	2017-04-06	211	2
K152953	CRIT-LINE CLIP (CLIC) BLOOD CHAMBER	Fresenius Medical Care North America	2015-11-05	29	0
K152367	Optiflux dialyzer	Fresenius Medical Care North America	2015-10-29	69	0
K123262	OPTIFLUX ULTRA DIALYZER	Fresenius Medical Care North America	2014-01-06	445	0
K131611	FRESENIUS DRY ACID DISSOLUTION UNITS	Fresenius Medical Care North America	2013-08-29	87	0
K124035	2008K@HOME HEMODIALYSIS MACHINE	Fresenius Medical Care North America	2013-07-03	187	0
K121341	FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM	Fresenius Medical Care North America	2012-12-06	217	5
K121599	CRIT-LINE CLIP (CLIC)	Fresenius Medical Care-North America	2012-11-09	161	0
K120017	FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM	Fresenius Medical Care North America	2012-02-02	30	3
K113427	FRESENIUS 2008T HEMODIALYSIS MACHINE	Fresenius Medical Care North America	2011-12-21	30	4
K070049	FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR	Fresenius Medical Care North America	2011-02-03	1491	7
K093902	MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL	Fresenius Medical Care North America	2010-05-27	156	2
K080964	FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE	Fresenius Medical Care North America	2009-01-14	285	4
K083542	FRESENIUS STERILE STAY SAFE CAP	Fresenius Medical Care North America	2008-12-29	31	1
K082414	OPTIFLUX F250NR, MODEL 0500325E	Fresenius Medical Care North America	2008-10-28	68	3
K071387	FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE,	Fresenius Medical Care North America	2007-06-15	28	6
K070222	FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N	Fresenius Medical Care North America	2007-04-24	90	0
K070177	FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND	Fresenius Medical Care North America	2007-03-29	70	32
K060734	FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; F	Fresenius Medical Care North America	2006-09-05	169	0
K050273	FRESENIUS ART HEMOADSORPTION SYSTEM	Fresenius Medical Care North America	2005-06-08	121	0
K043363	FRESENIUS LIBERTY CYCLER	Fresenius Medical Care North America	2005-03-31	114	8
K043244	FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR	Fresenius Medical Care North America	2004-12-20	27	1
K041792	FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211	Fresenius Medical Care North America	2004-09-24	84	0
K041042	SPLIT SEPTUM INJECTION SITES	Fresenius Medical Care North America	2004-07-16	85	0
K034064	FRESENIUS ULTRAFLO HPX HEMODIALYZER	Fresenius Medical Care North America	2004-01-30	30	0
K031378	FRESENIUS ULTRAFLUX HEMODIALYZER	Fresenius Medical Care North America	2003-05-30	29	0
K022412	FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH	Fresenius Medical Care North America	2003-03-05	224	5
K021060	FRESENIUS ICARE MONITORING SYSTEM	Fresenius Medical Care North America	2002-11-13	225	0
K012242	FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIU	Fresenius Medical Care North America	2001-08-16	30	0
K010268	FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-900	Fresenius Medical Care North America	2001-04-27	88	0
K002892	FRSENIUS PD IQCARD CYCLER	Fresenius Medical Care North America	2001-04-05	202	1
K003498	FRESENIUS OPTIFLUX 200A	Fresenius Medical Care North America	2001-01-04	52	2
K002761	FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS	Fresenius Medical Care North America	2000-12-04	90	2
K003445	FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYS	Fresenius Medical Care North America	2000-12-01	25	0
K002277	FRESENIUS OPTIFLUX 200NR	Fresenius Medical Care North America	2000-08-25	30	6
K001873	HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 0	Fresenius Medical Care North America	2000-07-28	38	0
K001107	FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-	Fresenius Medical Care North America	2000-06-23	79	0
K000702	BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTO	Fresenius Medical Care North America	2000-06-07	98	0
K000451	FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALO	Fresenius Medical Care North America	2000-05-09	88	0
K982926	FRESENIUS BLOOD VOLUME MONITOR	Fresenius Medical Care North America	1999-09-03	379	0
K991520	FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACC	Fresenius Medical Care North America	1999-07-30	88	0
K974090	95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZER	Fresenius Medical Care North America	1998-08-27	302	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda