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

LDF — Predicate Candidate Screening

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

88 daysmedian FDA review time

280 days90th percentile

130clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252042	Sync AV II Temporary Pacing Catheter	Swift Sync, Inc.	2026-07-30	395	0
K242863	Bioptimal Bipolar Pacing Catheter	Bioptimal International Pte. , Ltd.	2025-06-15	268	0
K251186	Bard® Temporary Pacing Electrode Catheter Needle / Cannula (	C.R. Bard, Inc.	2025-05-15	29	0
K241334	Semi-Floating Temporary Pacing Electrode Catheter, Bipolar,	C.R. Bard, Inc.	2025-01-31	266	0
K241199	Rotatable Connector (5944RL)	Shenzhen Launch Electrical Co., Ltd.	2025-01-23	268	0
K242705	Streamline Unipolar Pediatric Temporary Pacing Lead (6491) S	Medtronic, Inc.	2025-01-17	130	0
K232261	TME Temporary Myocardial Electrode	Osypka AG	2024-04-26	270	0
K190716	Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, St	Medtronic	2019-08-08	142	0
K173923	Temporary Cardiac Pacing Wire	ETHICON, Inc.	2018-08-02	219	0
K171253	Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, St	Medtronic	2017-05-25	27	0
K161873	Pacel Flow Directed Pacing Catheter	St Jude Medical	2016-11-22	138	0
K160260	Tempo Temporary Pacing Lead	Biotrace Medical, Inc.	2016-10-25	267	0
K161249	Streamline 6495 Bipolar Temporary Myocardial Pacing Lead	Medtronic	2016-08-19	108	0
K152784	Pacel Bipolar Pacing Catheters	St Jude Medical	2015-10-22	27	0
K152633	Chandler Transluminal Bipolar Pacing Probe, Flextip Translum	Edwards Lifesciences, LLC	2015-10-15	30	0
K140972	UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY	Medtronic, Inc.	2014-06-06	51	0
K072770	TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM)	Oscor, Inc.	2008-01-22	116	0
K042190	MODEL 6416 TEMPORARY PACING LEAD SYSTEM	Medtronic Vascular	2004-09-07	26	0
K040812	DETECT SURGICAL PACING AND MAPPING TOOL	Medtronic Vascular	2004-09-02	157	0
K033858	TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE	European Custom Manufacturing BV	2004-07-12	214	1
K032613	TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE	Peter M. Rothenberg, M.D.	2003-11-20	87	0
K023174	DISPOSABLE TEMPORARY PACING WIRE	River Medical, Inc.	2003-06-11	261	0
K030556	STEELEX ELECTRODE SET	Aesculap, Inc.	2003-04-22	60	0
K011660	WECK CARDIAC PACING WIRES	Weck Closure Systems	2001-08-21	84	0
K012460	MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD	Medtronic Vascular	2001-08-14	13	0
K012452	MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD	Medtronic Vascular	2001-08-14	13	0
K012454	MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD	Medtronic Vascular	2001-08-14	13	0
K012458	MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD	Medtronic Vascular	2001-08-14	13	0
K012459	MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE	Medtronic Vascular	2001-08-14	13	0
K010099	ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER	Zcv ,Inc.	2001-02-01	21	0
K002603	ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CAT	Zcv ,Inc.	2001-01-08	139	0
K002481	ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X	Zcv ,Inc.	2000-12-07	115	0
K002687	ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-0	Zynergy Cardiovascular, Inc.	2000-11-09	72	0
K973360	MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LE	Medtronic Vascular	1998-05-26	260	0
K980503	TEMPORARY CARDIAC PACING WIRE	ETHICON, Inc.	1998-04-10	60	0
K971775	INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610	Cardiac Control Systems, Inc.	1997-12-29	230	0
K955829	SAFPACE SYSTEM	B.Braun Medical, Inc.	1997-11-18	693	0
K962833	HARMAC TEMPORARY PACING CATHETER WITH BALLOON	Harmac Medical Products, Inc.	1997-10-15	474	0
K963073	HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET	Harmac Medical Products, Inc.	1997-08-14	412	0
K971165	INTRODUCER SHEATH AND DILATOR	Boston Scientific Corp	1997-07-23	114	0
K963898	MODEL 6495 BIPOLAR TEMPORARY PACING LEAD	Medtronic Vascular	1997-07-22	298	1
K961520	UNIPOLAR IPG GROUND CABLE, MODEL 5473	Medtronic Vascular	1996-11-13	205	0
K960479	ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER	Arrow Intl., Inc.	1996-10-17	258	4
K955712	USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING	C.R. Bard, Inc.	1996-10-11	301	0
K962467	RV PACING LEAD	Abbott Laboratories	1996-09-17	84	0
K955722	FLEXON TEMPORARY CARDIAC PACER LEAD	Davis & Geck, Inc.	1996-03-15	88	0
K954809	UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494	Medtronic Vascular	1995-12-13	55	0
K934785	MULTIPACE	Electro-Catheter Corp.	1995-07-27	660	0
K944957	TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500	Medtronic Blood Systems, Inc.	1995-07-14	280	0
K944956	UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491	The Heart Valve Div. Medtronic Cardiovascular Surg	1995-07-14	280	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