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

LQC — Predicate Candidate Screening

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

72 daysmedian FDA review time

209 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K040447	TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 10	Boston Scientific Corp	2004-03-12	21	0
K011178	WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR	Wilson-Cook Medical, Inc.	2001-05-04	17	0
K964937	A LITHOTRIPTER-COMPATIBLE BASKET	Boston Scientific Corp	1997-01-24	45	0
K942544	GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS	Medi-Globe Corp.	1994-11-22	175	0
K943191	MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR	Boston Scientific Corp	1994-08-29	55	0
K905552	LAPAROLITH	Baxter Healthcare Corp	1991-12-17	371	0
K911364	SPOON FORCEPS, 11MM	Northgate Technologies, Inc.	1991-10-23	209	0
K911477	LAPAROSCOPIC BASKET FLEXIBLE AND RIGID	United States Endoscopy Group, Inc.	1991-08-14	132	0
K903529	BML SERIES	Olympus Corp.	1991-01-23	170	4
K902170	SOEHENDRA LITHOTRIPSY SET	Wilson-Cook Medical, Inc.	1990-07-25	72	0
K860863	ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER	George Percy Mcgown	1986-05-15	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