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

Vitrolife Sweden AB — Predicate Candidate Screening

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

156 daysmedian FDA review time

324 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K243373	Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo	Vitrolife Sweden AB	2025-07-23	266	0
K241662	Ultrasound Transducer Cover	Vitrolife Sweden AB	2024-08-30	81	0
K240605	Ultra RapidWarm™ Blast	Vitrolife Sweden AB	2024-08-07	156	0
K202862	Gx-IVF, Gx-TL, Gx-MOPS PLUS	Vitrolife Sweden AB	2021-05-14	228	0
K183486	RapidVit™ Oocyte, RapidWarm™ Oocyte	Vitrolife Sweden AB	2019-07-26	221	0
K181461	Rapid-i™ Kit	Vitrolife Sweden AB	2019-01-04	214	0
K172050	Follicle Aspiration Set, Reduced Single Lumen	Vitrolife Sweden AB	2017-11-21	138	0
K161970	Follicle Aspiration Set	Vitrolife Sweden AB	2017-06-14	331	0
K150950	FreezeKit Cleave , ThawKit Cleave	Vitrolife Sweden AB	2015-12-21	257	0
K140207	RAPID-I KIT	Vitrolife Sweden AB	2014-12-18	324	0
K113786	SPERMFREEZE SOLUTION	Vitrolife Sweden AB	2012-10-26	309	0
K101003	RAPIDVIT BLAST, RAPIDWARM BLAST	Vitrolife Sweden AB	2010-12-10	242	0
K090832	RAPID-I	Vitrolife Sweden AB	2009-12-23	272	0
K082727	FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN	Vitrolife Sweden AB	2009-02-06	142	0
K080446	RAPIDVIT AND RAPIDWARM CLEAVE	Vitrolife Sweden AB	2008-11-26	281	0
K081997	PERFADEX WITH THAM	Vitrolife Sweden AB	2008-10-09	87	1
K081115	G-MOPS G5 SERIES	Vitrolife Sweden AB	2008-09-17	152	0
K081117	G-2 V5	Vitrolife Sweden AB	2008-09-16	151	0
K081114	G-1 V5	Vitrolife Sweden AB	2008-09-16	151	0
K081116	G-IVF G5 SERIES	Vitrolife Sweden AB	2008-09-02	137	0
K043116	ICSI-100	Vitrolife Sweden AB	2005-01-13	64	0
K033101	G-PGD	Vitrolife Sweden AB	2004-05-07	221	0
K032877	G-OOCYTE	Vitrolife Sweden AB	2004-05-07	235	0
K031015	EMBRYOGLUE	Vitrolife Sweden AB	2003-06-23	84	0
K023403	SPERMGRAD, MODELS 10022/10063	Vitrolife Sweden AB	2002-12-13	64	0
K022295	G-RINSE, MODEL 10031	Vitrolife Sweden AB	2002-09-12	58	0
K022244	G-1 VERSION 3, MODEL 10048	Vitrolife Sweden AB	2002-09-06	56	0
K022247	G-SPERM, MODEL 10032	Vitrolife Sweden AB	2002-09-06	56	0
K021893	G-MOPS, MODEL 10030	Vitrolife Sweden AB	2002-09-06	88	0
K021890	G-2 VERSION 3, MODEL 10049	Vitrolife Sweden AB	2002-09-06	88	0
K021894	G-MM, MODEL 10038	Vitrolife Sweden AB	2002-09-06	88	0
K021896	HSA-SOLUTION, MODEL 10034/10064	Vitrolife Sweden AB	2002-09-06	88	0
K022245	G-FERT, MODEL 10033	Vitrolife Sweden AB	2002-09-06	56	0
K000881	PERFADEX SOLUTION FOR ORGAN PRESERVATION	Vitrolife Sweden AB	2001-03-08	353	0
K991348	IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 242	Vitrolife Sweden AB	2000-05-17	394	0
K991351	OVOIL-150, MODEL 5002	Vitrolife Sweden AB	2000-02-25	312	0
K991346	PH-100, MODEL 2104	Vitrolife Sweden AB	2000-02-24	311	0
K991345	ASP-100, MODEL 2100	Vitrolife Sweden AB	2000-02-18	305	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