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

DRB — Predicate Candidate Screening

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

79 daysmedian FDA review time

248 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days
K220280	Arrow Stiffening Stylet	Arrow International, LLC (A subsidiary of Teleflex, Inc.)	2022-08-30	210
K191469	Biotronik Stylets	Biotronik, Inc.	2019-08-01	59
K182660	GaltTWS	Galt Medical Corp.	2019-05-30	247
K170298	Liberator Beacon Tip Locking Stylet	Cook Incorporated	2017-10-18	260
K142116	LLD EZ	Spectranetics, Inc.	2014-08-12	8
K090163	STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078	St Jude Medical	2009-04-01	69
K080924	MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151	St. Jude Medical, Cardiac Rhythm Management Divisi	2008-04-30	28
K072864	ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM	St. Jude Medical, Cardiac Rhythm Management Divisi	2008-03-13	160
K053019	ACUITY STEERABLE STYLET ACCESSORY	Guidant Corporation	2006-03-03	128
K052965	EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.	Guidant Corporation	2006-02-13	115
K043401	SPECTRANETICS LLD CS, MODEL 518-039	Spectranetics Corp.	2005-03-16	96
K040001	STEERABLE STYLET	Synovis Surgical Innovations	2004-03-09	67
K010906	MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254	Medtronic Vascular	2001-04-05	10
K003535	STYLET KIT, MODELS 6254,6282,6293	Medtronic Vascular	2001-02-08	84
K002534	EUPALAMUS DEFLECTABLE STYLET, MODEL 01545	Eupalamus, LLC	2000-10-18	63
K000955	PLACER MODEL 6232 STEERABLE STYLET	Medtronic Vascular	2000-06-16	84
K000366	FIXATION STYLETS, MODELS 335-287 AND 335-288	Accufix Research Institute	2000-04-14	70
K992664	TFX MEDICAL STYLET CATHETER	Tfx Medical Group	2000-04-13	248
K993376	ENSTYLET MODELS EC0010, EC0020	Endocardial Solutions, Inc.	2000-01-05	90
K992863	LEAD STYLET,MODELS 6505,6506,6507,6508	Guidant Corp.	1999-11-12	79
K990713	SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER	Spectranetics Corp.	1999-10-22	232
K914001	TARGET THERAPEUTICS RADIOPAQUE STYLET	Target Therapeutics	1991-11-22	77
K913543	THORACIC CATHETER STYLET	Intl. Medical Devices , Ltd.	1991-10-04	56
K901281	THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER	Val-Mark Medical, Inc.	1991-08-28	527
K905674	LEAD STYLET	Cardiac Pacemakers, Inc.	1991-01-30	43
K882097	TUNNELING STYLET	Quinton, Inc.	1988-07-28	70
K802076	STIFF STYLETS	Cardiac Pacemakers, Inc.	1980-09-26	29
K770404	OBTURATOR	Abbott Laboratories	1977-03-16	13

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