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

OCY — Predicate Candidate Screening

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

57 daysmedian FDA review time

143 days90th percentile

43clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K153264	EasyPass Guidewire	Medi-Globe Corporation	2016-05-19	189	0
K151471	Radifocus Glidewire Endoscopic Wire	Terumo Medical Corporation	2015-09-17	108	0
K150927	Orchestra Hydrophilic Guidewire standard angled, Orchestra H	Coloplast A/S	2015-05-27	51	0
K150225	NovaGold High Performance Guidewire	Neometrics, Inc.	2015-03-16	42	0
K142950	Acrobat Calibrated Tip Wire Guide	Wilson-Cook Medical, Inc.	2014-11-05	26	0
K141820	JAGWIRE HIGH PERFORMANCE GUIDWIRE	Boston Scientific Corp	2014-10-21	106	0
K142397	Predicate III Guidewire	Lake Region Medical	2014-09-19	23	0
K140482	MANDREL GUIDEWIRE	Lake Region Medical	2014-04-08	41	0
K133076	NOVAGOLD HIGH PERFORMANCE GUIDEWIRE	Neometrics, Inc.	2014-02-20	143	1
K131072	ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA H	Coloplast A/S	2013-07-09	83	0
K124052	OSTAVI HYDROPHILIC GUIDEWIRE	Lake Region Medical	2013-02-26	57	0
K123438	XENX STONE MANAGEMENT DEVICE	Xenolith Medical	2013-01-10	63	0
K123439	NEO ERCP GUIDEWIRE	Neometrics, Inc.	2013-01-03	56	0
K122816	AXCESS SOFT TIP WIRE GUIDE	Wilson-Cook Medical, Inc.	2012-10-09	25	0
K113692	XENX	Xenolith Medical	2012-08-09	238	0
K091417	SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240	Terumo Corp.	2009-05-22	9	0
K082536	COOK WIRE GUIDES	Cook Urological, Inc.	2008-10-27	55	1
K081708	TAXI ENDOSCOPIC GUIDEWIRE	Lake Region Mfg., Inc.	2008-08-26	70	0
K080508	MANDREL GUIDEWIRES OR M-WIRE	Lake Region Medical	2008-03-21	25	0
K072354	GUIDEWIRE, MODEL G-V220-3527S AND OTHERS	Accellent, Inc.	2007-12-07	107	0
K060034	NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC US	Nipro Medical Corporation	2006-02-28	54	0
K053028	TECHDEVICE GUIDEWIRE	Techdevice Corporation	2006-01-31	96	0
K050304	FX WIRE ADVANCED MEASUREMENT GUIDEWIRE	Conmedcorp	2005-03-08	28	0
K040137	WILSON-COOK USW CAP AND WIRE LOCK	Wilson-Cook Medical, Inc.	2004-02-20	29	0
K033754	TRACER METRO SMART WIRE GUIDE	Wilson-Cook Medical, Inc.	2003-12-30	29	0
K023603	ENDO-GLIDE GUIDEWIRE	Endo-Therapeutics, Inc.	2003-02-19	114	0
K021179	DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A	Olympus Optical Co., Ltd.	2002-07-05	81	0
K011759	RADIUS NEXT GENERATION GUIDEWIRE	Radius Medical Technologies, Inc.	2001-08-23	78	0
K990765	FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK	Flexmedics	1999-03-15	7	0
K971937	CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE	Terumo Medical Corp.	1997-08-15	80	0
K964780	BARD DIRECTOR GUIDEWIRE (000560)	C.R. Bard, Inc.	1997-02-26	91	0
K964955	FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK	Flexmedics	1997-02-14	65	0
K962178	BARD TIGER GUIDEWIRE MODEL 000540	C.R. Bard, Inc.	1996-10-29	145	0
K944959	AMPLATZ SUPER STIFF GUIDEWIRE	Boston Scientific Corp	1994-11-04	28	0
K943737	MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER	Boston Scientific Corp	1994-08-17	15	0
K933110	OLYMPUS GUIDE WIRE	Olympus Corp.	1993-11-04	132	0
K923755	FLEX FINDER GUIDEWIRE	Flex Medics Corporation	1993-09-03	406	0
K931650	MICROVASIVE INSURG GEENEN CBD GUIDE WIRE	Boston Scientific Corp	1993-06-25	81	0
K910497	WILSON COOK WIRE GUIDE AND PROTECTIVE GUIDE	Wilson-Cook Medical, Inc.	1991-04-02	56	0
K910722	450CM GUIDE WIRE FOR G.I. USE	Terumo Corp.	1991-03-21	29	0
K901429	SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE	Telemed Systems, Inc.	1990-06-05	71	0
K892648	MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177	Boston Scientific Corp	1989-05-24	42	0
K813026	GUIDE WIRE	Inmed Corp.	1981-11-17	20	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