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

MQF — Predicate Candidate Screening

53 FDA 510(k) clearances under this product code; the 50 most recent screened below.

135 daysmedian FDA review time

266 days90th percentile

53clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253354	Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C,	Guangzhou Hehong Biotech Co., Ltd.	2026-02-12	135	0
K243373	Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo	Vitrolife Sweden AB	2025-07-23	266	0
K240307	VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A	Shenzhen Vitavitro Biotech Co., Ltd.	2024-08-16	196	0
K231730	FemaSeed Intratubal Insemination	Femasys, Inc.	2023-09-22	101	0
K220010	Daylily Single Use Sterile Embryo Transfer Catheter	Shanghai Horizon Medical Technology Co., Ltd.	2022-12-16	346	0
K200248	Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets a	Allwin Medical Devices, Inc.	2020-07-01	152	0
K192540	Kitazato ET Catheters	Kitazato Corporation	2020-05-01	228	0
K190522	Allwin Intra Uterine Insemination Catheters (INSEMINA and IN	Allwin Medical Devices, Inc.	2019-11-14	255	0
K191015	Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embr	Cook Incorporated	2019-05-17	30	0
K180302	Guardia™ Access Malleable Obturator, Guardia™ Obturator, Sof	Cook Incorporated	2018-10-24	264	0
K173431	Towako Transmyometrial Embryo Transfer Set	William A. Cook Australia Pty. , Ltd.	2018-05-18	197	0
K173103	Pivet and Soft-Pass Embryo Transfer Catheter Sets	Cook Incorporated	2018-04-13	196	0
K173686	Guardia Access Embryo Transfer Catheter Sets and Sydney IVF®	Cook Incorporated	2018-04-11	131	0
K172051	Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter	Cook Incorporated	2018-01-10	188	0
K172321	Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauter	Cook Incorporated	2017-12-21	142	0
K163318	Soules Intrauterine Insemination Catheter	Cook Incorporated	2017-07-14	233	0
K162878	Kitazato ET Catheters	Kitazato Corporation	2017-07-13	272	0
K162667	Kitazato IUI Catheter	Kitazato Corporation	2017-05-11	227	0
K161547	Transem and EchoGen Embryo Transfer Catheters	Origio A/S	2017-03-09	279	0
K162064	CrossBay IVF Embryo Transfer Catheter Set	Crossbay Medical, Inc.	2017-01-05	163	0
K143669	MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedG	Medgyn Products, Inc.	2015-11-23	334	0
K141666	FERTILIGENT SLOW RELEASE IUI CATHETER KIT	Fertiligent, Ltd.	2015-02-03	225	0
K131491	KITAZATO IUI CATHETER	Kitazato Medical Co., Ltd.	2013-09-11	111	0
K112396	IUI CATHETERS	Kitazato Medical Co., Ltd.	2012-11-02	441	0
K120154	INTRAUTERINE INSEMINATION (IUI) CATHETER	Catheter Research, Inc.	2012-03-21	63	0
K092579	INTRAUTERINE INSEMINATION (IUI) CATHETER	Fertiligent, Ltd.	2010-04-02	228	0
K053208	CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B	Swemed Lab International AB	2006-01-30	75	0
K052059	IUI CATHETER, MODEL 9057	Inntec, Inc.	2005-11-22	116	0
K050521	EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018,	Inntec, Inc.	2005-05-02	62	0
K041470	MORTON IUI CATHETERS	Fertility Technology Resources, Inc.	2004-11-22	173	1
K033084	WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TR	Portex , Ltd.	2003-12-19	81	6
K023382	COOPERSURGICAL MALLEABLE SYTLET	Cooper Surgical	2002-12-20	73	0
K023017	TUCKER EMBRYO CATHETER	Fertility Technology Resources, Inc.	2002-12-13	94	1
K023384	COOPERSURGICAL TRIAL TRANSFER CATHETER	Cooper Surgical	2002-12-13	66	0
K023383	COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER	Cooper Surgical	2002-12-13	66	0
K023379	COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSI	Cooper Surgical	2002-12-11	64	0
K013536	EMTRAC; DELPHIN; SEMTRAC 2000 SET	Gynetics Medical Products NV	2001-11-30	38	0
K013501	IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502	Gynetics Medical Products NV	2001-11-30	39	0
K012220	TAO EMBRYO TRANSFER CATHETER SYSTEM	Ttj Biomedical, LLC	2001-08-27	42	0
K000950	EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201	Labotect Labor-Technik Gottingen	2000-05-12	50	0
K000656	EMBRYON GIFT TRANSFER CATHETERS/SETS	Rocket Medical Plc	2000-03-09	10	0
K994327	EMBRYON TRANSFER CATHETERS/SETS	Rocket Medical Plc	2000-02-28	68	0
K992307	EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FO	Fertility Technology Resources, Inc.	1999-09-13	66	0
K991266	<GENX> EMBRYO TRANSFER CATHETER CC GLIDER	<Genx> Intl., Inc.	1999-09-09	149	0
K990348	WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N	CooperSurgical, Inc.	1999-07-26	171	0
K990349	WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEAB	CooperSurgical, Inc.	1999-07-26	171	6
K990350	WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM,	CooperSurgical, Inc.	1999-07-26	171	6
K983604	INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER	Washington Regulatory Services	1999-05-27	225	0
K983595	TRANSMYOMETRIAL EMBRYO TRANSFER SET	Cook Ob/Gyn	1999-02-08	118	0
K983594	EMBRYO TRANSFER CATHETERS/SETS	Cook Ob/Gyn	1998-12-21	69	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