Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Jostra AG — Predicate Candidate Screening

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

85 daysmedian FDA review time

304 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K020983	JOSTRA SUCKERS, MODEL JS	Jostra AG	2004-01-30	674	0
K030264	QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HM	Jostra AG	2003-02-26	30	0
K020784	JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS	Jostra AG	2003-01-09	304	0
K023132	JOSTRA MECC SYSTEM	Jostra AG	2002-12-17	88	0
K022022	JOSTRA VENT CATHETERS, MODELS LV & HKV	Jostra AG	2002-09-11	83	0
K020515	JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA	Jostra AG	2002-04-24	68	0
K014303	JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE	Jostra AG	2002-03-26	85	0
K013944	JOSTRA DUAL STAGE VENOUS RETURN CANNULAE	Jostra AG	2002-02-11	74	0
K013939	JOSTRA FLOWPROBE FP-32E	Jostra AG	2001-12-14	15	0
K012774	JOSTRA ARTERIAL PERFUSION CANNULAE	Jostra AG	2001-11-16	88	0
K012617	JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...	Jostra AG	2001-11-06	85	0
K003551	VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201	Jostra AG	2001-07-11	236	0
K002857	ELS CANNULA (KIT), MODEL M1210-88,M1510-88	Jostra AG	2000-10-05	22	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