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

MQE — Predicate Candidate Screening

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

138 daysmedian FDA review time

270 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253121	Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Doub	Gimbo Medical Technology Shenzhen Co., Ltd.	2026-06-15	263	0
K240523	VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, O	Shenzhen Vitavitro Biotech Co., Ltd.	2024-11-15	266	0
K232163	Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lume	Zhejiang Horizon Medical Technology Co., Ltd.	2024-02-22	216	0
K190590	Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Nee	Allwin Medical Devices, Inc.	2019-11-25	263	0
K191291	Wallace Dual Lumen Oocyte Recovery System	CooperSurgical, Inc.	2019-06-12	29	0
K182959	Wallace Dual Lumen Oocyte Recovery System	CooperSurgical, Inc.	2019-05-10	197	0
K171625	Single Lumen Ovum Aspiration Needles	Willian A. Cook Australia Pty, Ltd.	2018-01-12	224	0
K171611	Double Lumen Ovum Aspiration Needles	William A. Cook Australia Pty. , Ltd.	2017-12-15	197	0
K172050	Follicle Aspiration Set, Reduced Single Lumen	Vitrolife Sweden AB	2017-11-21	138	0
K162881	Kitazato OPU Needles	Kitazato Corporation	2017-07-11	270	0
K161970	Follicle Aspiration Set	Vitrolife Sweden AB	2017-06-14	331	0
K141365	OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN	William A. Cook Australia Pty. , Ltd.	2014-08-07	76	0
K112462	KITAZATO OPU NEEDLE	Kitazato Medical Co., Ltd.	2012-11-26	458	0
K082727	FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN	Vitrolife Sweden AB	2009-02-06	142	0
K051742	OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH	Inntec, Inc.	2005-10-07	101	0
K032208	MONA LISA ASPIRATION NEEDLE	Fertility Technology Resources, Inc.	2003-12-09	144	0
K032015	EMBRYON ULTRASOUND NEEDLE GUIDE	Rocket Medical Plc	2003-08-08	39	0
K031622	WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS	Portex , Ltd.	2003-06-26	34	0
K023930	COOPERSURGICAL OOCYTE RECOVERY NEEDLES	CooperSurgical, Inc.	2003-01-22	58	0
K013497	FAS SET #4551	Gynetics Medical Products NV	2001-11-09	18	0
K012068	WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL	Sims Portex , Ltd.	2001-08-03	32	1
K003056	OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-	Labotect Labor-Technik Gottingen	2000-12-13	73	0
K000205	EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES	Rocket Medical Plc	2000-04-19	89	0
K000628	WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE O	Sims Portex , Ltd.	2000-03-13	18	1
K991271	OOCYTE ASPIRATION NEEDLE	Casmed UK	2000-03-08	330	0
K994417	OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WIT	Cook Urological, Inc.	2000-03-01	63	0
K992308	OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138	Lifetek Medical, Inc.	1999-09-13	66	0
K991262	<GEN>SINGLE LUMEN NEEDLE	<Genx> Intl., Inc.	1999-09-09	149	0
K991264	<GENX> SINGLE LUMEN SIDEPORT NEEDLE	<Genx> Intl., Inc.	1999-09-09	149	0
K991020	<GENX> DOUBLE LUMEN NEEDLE	<Genx> Intl., Inc.	1999-09-09	164	0
K991273	SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN,	Swemed Lab International AB	1999-08-18	127	0
K990913	HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALV	Laboratoires Prodimed	1999-06-08	82	0
K983593	OVUM PICK-UP ASPIRATION NEEDLES	Cook Ob/Gyn	1999-01-21	100	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