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

Fresenius Medical Care North America, Design Cente · Predicate Candidate Screening

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

186 daysmedian FDA review time

290 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K123630	FRESENIUS LIBERTY CYCLER	Fresenius Medical Care North America, Design Cente	2013-09-09	290	1
K121421	FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETN	Fresenius Medical Care North America, Design Cente	2013-01-17	248	2
K120823	BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET	Fresenius Medical Care North America, Design Cente	2012-06-15	88	0
K120505	FRESENIUS 2008T HEMODIALYSIS MACHINE	Fresenius Medical Care North America, Design Cente	2012-03-06	14	4
K101715	FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573	Fresenius Medical Care North America, Design Cente	2010-12-21	186	1

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