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

DRC — Predicate Candidate Screening

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

108 daysmedian FDA review time

228 days90th percentile

51clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K240246	Accusafe Transseptal Guidewire (GTR31180, GTR31230)	Synaptic Medical Corporation	2024-07-26	178	0
K241042	SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098,	Pressure Products Medical Device Manufacturing, LLC	2024-05-17	30	0
K221707	SafeSept® Transseptal Guidewire (SS-140)	Pressure Products Medical Device Manufacturing, LLC	2022-09-14	93	0
K212625	PathBuilder Transseptal Needle	Shanghai Microport EP Medtech Co., Ltd.	2022-03-23	217	0
K210328	SafeSept Blunt Needle	Pressure Products Medical Device Manufacturing, LLC	2021-03-05	29	0
K172950	TSN Transseptal Needle	Pressure Products Medical Device Manufacturing, LLC	2018-02-21	148	0
K172934	Needle Free Transseptal Cannula	Pressure Products Medical Device Manufacturing, LLC	2018-02-16	144	0
K172893	SafeSept Needle Free Transseptal Guidewire	Pressure Products Medical Device Manufacturing, LLC	2017-12-21	90	0
K170671	SafeSept Transseptal Guidewire	Pressure Products Medical Device Manufacturing, LLC	2017-10-20	228	0
K132943	INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE	Synaptic Medical Limited	2014-08-29	344	0
K130843	SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE	Oscor, Inc.	2014-01-08	287	0
K122587	BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206,	St Jude Medical	2013-02-07	167	0
K122832	MOBICATH TRANSSEPTAL NEEDLE	Great Batch Medical	2012-12-19	93	0
K111644	MOBICATH TRANSSEPTAL NEEDLE	Great Batch Medical	2011-10-03	112	0
K081986	SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE	Oscor, Inc.	2008-11-14	123	0
K072278	BRK TRANSSEPTAL NEEDLE	St Jude Medical	2007-09-13	28	0
K061070	HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR	Hansen Medical, Inc.	2006-10-13	179	0
K022117	MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-	Merit Medical Systems, Inc.	2002-10-11	102	0
K022257	VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090	Vomed Volzer Medizintechnik GmbH & Co.	2002-10-04	84	0
K011727	TRANSSEPTAL NEEDLE/TROCAR	Thomas Medical Products, Inc.	2002-05-02	332	0
K011373	INSTRUMENT DAMPING PORT	Medcanica, Inc.	2001-10-12	161	0
K011349	INTERCOSTAL LOCKABLE-DIRECTABLE PORT	Medcanica, Inc.	2001-10-05	156	0
K974743	MANAN	Medical Device Technologies, Inc.	1998-04-06	108	0
K974742	MANAN POTTS-COURNAND NEEDLE	Medical Device Technologies, Inc.	1998-04-06	108	0
K974745	MANAN GWI GUIDE WIRE INTRODUCER	Medical Device Technologies, Inc.	1998-04-06	108	1
K964302	HEARTPORT THORACIC TROCAR	Heartport, Inc.	1997-05-09	192	0
K965051	HEARTPORT NEEDLE TROCAR	Heartport, Inc.	1997-03-12	84	0
K951448	GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEED	Global Medical Products, Ltd.	1996-03-27	364	0
K936247	MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SL	Medicon Instruments, Inc.	1994-05-19	140	0
K940036	ENDOSURG DISPOSABLE SECONDARY TROCAR	Endosurg	1994-05-12	128	0
K924338	ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE	Arrow Intl., Inc.	1993-03-18	203	0
K913267	R-GROUP INTL. ONE WALL PUNCTURE NEEDLE	R-Group Intl.	1992-06-05	318	0
K914985	DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION	E-Z-Em, Inc.	1991-12-20	58	0
K911483	LAPAROSCOPIC TROCAR	United States Endoscopy Group, Inc.	1991-07-02	89	0
K911462	SURGICAL TROCAR	Applied Medical	1991-04-22	19	1
K900664	DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES	Sterimed, Inc.	1990-07-18	155	0
K895454	SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK)	Advance Medical Designs, Inc.	1989-11-14	70	0
K895455	SELDINGER PERCUTANEOUS 2 PC NEEDLES	Advance Medical Designs, Inc.	1989-11-14	70	0
K893707	AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT	United States Surgical, A Division of Tyco Healthc	1989-06-15	28	0
K890209	DISPOSABLE ANGIOGRAPHY NEEDLES	E-Z-Em, Inc.	1989-05-19	122	0
K871377	NAMIC COURNAND STYLE INTRODUCER NEEDLE	North American Instrument Corp.	1987-05-07	30	0
K871382	NAMIC ONE PART INTRODUCER NEEDLE	North American Instrument Corp.	1987-05-06	29	0
K871378	NAMIC SELDINGER INTRODUCER NEEDLE	North American Instrument Corp.	1987-05-06	29	0
K854293	MEDSURG POTT-COURNAND NEEDLE	Medsurg Industries, Inc.	1986-01-15	82	0
K854294	MEDSURG SELDINGER NEEDLE	Medsurg Industries, Inc.	1986-01-13	80	0
K853132	EMERSON TRO/CATH TROCAR CATHETERS	J. H. Emerson Co.	1986-01-08	166	0
K840529	STEIGER TUNNELING INSTRUMENT 285	Evermed, Inc.	1984-03-12	33	0
K811964	VISITEC NEEDLE RANGE (CARDIOVASCULAR)	Visitec Co.	1981-07-20	10	0
K781221	DILUTION KIT, THERMAL, COLD PAC	Instrumentation Laboratory CO	1978-08-23	37	0
K772369	NEEDLES USED IN ANGIOGRAPHIC PROCED.	Argon Medical Corp.	1978-01-24	28	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