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

Origio A/S — Predicate Candidate Screening

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

142 daysmedian FDA review time

253 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K200815	VitriGuard	Origio A/S	2020-06-25	87	0
K180740	VitriGuard	Origio A/S	2018-05-04	43	0
K173624	ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO	Origio A/S	2018-03-02	98	0
K172197	SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS	Origio A/S	2017-10-13	84	0
K161547	Transem and EchoGen Embryo Transfer Catheters	Origio A/S	2017-03-09	279	0
K162833	VitriGuard	Origio A/S	2017-02-16	128	0
K153267	ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/	Origio A/S	2016-07-22	253	3
K152932	BlastGen	Origio A/S	2016-02-29	147	0
K140317	EMBRYOGEN	Origio A/S	2014-06-16	126	0
K133912	ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL R	Origio A/S	2014-05-14	142	0
K133387	ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM	Origio A/S	2014-04-29	175	0
K133707	SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM	Origio A/S	2014-04-16	133	0
K120136	EMBRYOGEN	Origio A/S	2012-09-26	253	0
K100367	MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 122	Origio A/S	2010-08-27	196	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