Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

LQR — Predicate Candidate Screening

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

102 daysmedian FDA review time

255 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K253056	Disposable Stone Extraction Basket	Zhejiang Soudon Medical Technology Co., Ltd.	2026-04-03	193	0
K243807	Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P	Olympus Medical Systems Corp.	2025-03-18	97	0
K243471	Extraction Basket	Micro-Tech (Nanjing) Co., Ltd.	2024-12-16	38	0
K240192	Single-use Extraction Baskets	Scivita Medical Technology Co., Ltd.	2024-10-15	265	0
K230598	Stone Extraction Baskets	Jiangsu Vedkang Medical Science and Technology Co., Ltd.	2023-09-12	193	0
K203322	SpyGlass Discover Retrieval Basket	Boston Scientific Corporation	2021-05-26	195	0
K201509	Disposable Stone Extraction basket	Hangzhou AGS MedTech Co., Ltd.	2020-12-16	194	0
K191789	Stonetome Stone Removal Device	Boston Scientific Corporation	2019-07-25	22	0
K182381	Wilson-Cook Mini Basket	Wilson-Cook Medical, Inc.	2018-10-30	60	0
K171969	Web II Memory Extraction Basket or Memory II Double Lumen Ex	Wilson-Cook Medical, Inc.	2018-03-28	271	0
K171915	Nathanson Transcystic Bile Duct Stone Exploration Pack	Cook Incorporated	2018-03-01	248	0
K173687	Strange Bile Duct Stone Exploration Set	Cook Incorporated	2017-12-15	14	1
K170898	Wittich Nitinol Stone Basket	Cook Incorporated	2017-12-12	260	0
K170811	Single Use Retrieval Nitinol Basket V	Olympus Medical Systems Corp.	2017-11-27	255	0
K173009	NCompass Nitinol Stone Extractors	Cook Incorporated	2017-11-07	41	1
K131642	RSH BILIARY STONE REMOVAL DEVICE	Rsh, LLC	2013-08-07	64	0
K091495	SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B	Olympus Medical Systems Corporation	2009-09-03	106	0
K090485	COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005,	Percutaneous Systems, Incorporated	2009-07-22	147	0
K071066	SPYCATCH STONE RETRIEVAL BASKET	Boston Scientific Corp	2007-06-29	74	0
K992941	LEMAITRE BILIARY CATHETER	Vascutech, Inc.	2000-01-12	134	0
K952149	KARL STORZ TAKE-APART ROTATING GRASPING FORCEPS	KARL STORZ Endoscopy-America, Inc.	1995-06-15	38	0
K946358	ENDOSCOPIC BILIARY CATHETER	Boston Scientific Corp	1995-04-11	102	9
K945295	LSVP INTERNATIONAL GRASPING FORCEPS	Lsvp Intl., Inc.	1995-03-08	128	0
K942005	GIP/MED-GLOBE STONE EXTRACTOR BASKETS	Medi-Globe Corp.	1994-11-22	211	0
K931115	HATCHER STONE-EMBOLIS EXTRACTOR	Ideal Medical, Inc.	1993-08-20	169	0
K925879	MICROVASIVE INSURG FLAT WIRE BASKETS	Boston Scientific Corp	1993-02-08	81	0
K926040	HELI-TECH RETRIEVAL BASKET	Cape Tech Medical Products	1992-12-23	22	0
K925495	MICROVASIVE INSURG HELICAL & MINI-HELICAL BASKETS	Boston Scientific Corp	1992-12-23	51	0
K925559	BILIARY STONE DISLODGER	Annex Medical, Inc.	1992-12-17	44	0
K915538	OVER THE WIRE STONE BASKET	Medical Dynamics, Inc.	1992-03-20	101	0
K904472	GLASSMAN STONE EXTRACTION SET	Wilson-Cook Medical, Inc.	1990-12-28	88	0
K902944	WITTICH NITINOL STONE BASKET	Cook, Inc.	1990-09-12	69	0
K902945	COPE NITINOL STONE BASKET	Cook, Inc.	1990-09-12	69	0
K894865	WILTEK BALLOON STONE EXTRACTOR	Wiltek Medical, Inc.	1989-12-21	143	0
K894866	WILTEK STONE EXTRACTOR	Wiltek Medical, Inc.	1989-12-21	143	0
K891588	TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE)	Ideal Medical, Inc.	1989-09-28	195	0
K862949	HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER	Oscor Medical Corp.	1986-10-31	87	0
K850489	ENDOSOPIC STENE MANIPULATING BALLOON	Mill-Rose Laboratory	1985-04-22	73	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