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

DTB · Predicate Candidate Screening

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

79 daysmedian FDA review time

231 days90th percentile

487clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K061212	BIOTRONIK ENDOCARDIAL PACING LEADS	Biotronik, Inc.	2006-07-10	70	0
K041809	PERMANENT PACING LEAD, MODEL PY2	Oscor, Inc.	2004-08-06	31	1
K040569	PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJ	Oscor, Inc.	2004-04-07	34	1
K031274	MODEL 5071 MYOCARDIAL PACING LEAD	Medtronic Vascular	2003-05-22	30	0
K031210	MODEL 4951M MYOCARDIAL UNIPOLAR LEAD	Metronic, Inc.	2003-05-16	29	0
K023205	ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP	Biotronik, Inc.	2003-04-24	211	0
K024053	PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB	Oscor, Inc.	2003-01-31	53	0
K023803	MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS	Biotronik, Inc.	2002-12-11	27	0
K023099	AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP	Biotronik, Inc.	2002-10-18	30	0
K021217	AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP	Biotronik, Inc.	2002-05-01	14	0
K010281	MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/1	Biotronik, Inc.	2002-04-09	434	0
K020669	PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETIT	Oscor, Inc.	2002-03-28	27	0
K013339	PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS	Oscor, Inc.	2001-11-08	30	0
K003918	OSCOR PERMANENT PACING LEAD RZ MODEL SERIES	Oscor, Inc.	2001-05-22	154	0
K003072	PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES	Biotronik, Inc.	2001-01-09	98	0
K001413	ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION	Biotronik, Inc.	2000-06-02	29	0
K994240	EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP,	Biotronik, Inc.	2000-04-13	119	0
K993448	STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ	Ela Medical, Inc.	2000-04-10	181	0
K000763	PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051	Biotronik, GmbH & Co.	2000-04-06	28	0
K000029	STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ	Ela Medical, Inc.	2000-04-04	90	0
K993139	YP 45/15-BP; YP 53/15-BP; YP 60/15-BP	Biotronik, Inc.	1999-12-17	88	0
K990142	HT, MODEL HT PB	Sulzer Oscor, Inc.	1999-07-30	192	0
K991169	SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854	Biotronik, Inc.	1999-07-01	85	0
K990483	RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124	Biotronik, Inc.	1999-06-03	107	0
K980869	SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120	Biotronik, Inc.	1998-09-10	188	0
K981083	RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX R	Biotronik, Inc.	1998-07-22	120	0
K972500	TIR/TIJ AND POLYROX	Biotronik, Inc.	1998-03-04	244	0
K972814	LOCATOR MODEL 4036	Pacesetter, Inc.	1998-02-23	209	0
K965106	ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115	Biotronik, Inc.	1998-01-27	403	0
K972574	STELA MODEL UJ45 PACING LEADS	Ela Medical, Inc.	1998-01-08	182	0
K963738	STELA MODEL BJ44 AND BJ45 PACING LEADS	Ela Medical, Inc.	1997-05-23	248	0
K964107	OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR	Oscor Medical Corp.	1997-04-01	168	0
K964604	BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE	Biotronik, Inc.	1997-03-10	112	0
K954610	MODEL 430-07 ENDOCARDIAL PACING LEAD	Intermedics, Inc.	1996-12-16	439	0
K955122	INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMP	Intermedics, Inc.	1996-11-04	361	0
K953044	UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WIT	Biotronik, Inc.	1996-09-27	455	0
K962036	MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRIC	Medtronic Vascular	1996-08-22	90	0
K962174	BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 0	Intermedics, Inc.	1996-08-21	77	0
K961936	MODEL 2188 CORONARY SINUS LEAD.	Medtronic Vascular	1996-08-15	87	0
K961679	TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVE	Medtronic Vascular	1996-07-30	90	0
K961118	MAXIM PF MODELS 033-581/033-590	Telectronics Pacing Systems, Inc.	1996-07-15	117	0
K943657	STERILIZATION	Telectronics Pacing Systems, Inc.	1996-06-24	698	0
K955550	CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD	Intermedics, Inc.	1996-06-19	197	0
K960281	IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTAB	Intermedics, Inc.	1996-06-18	151	0
K954719	INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PAC	Intermedics, Inc.	1996-02-27	137	0
K954714	AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)	Pacesetter, Inc.	1996-02-01	122	0
K954551	DF-1 TERMINAL CAP	Pacesetter, Inc.	1995-12-26	85	0
K954085	MODELS 5866-45 AND 5866-46 SIZING SLEEVE	Medtronic Vascular	1995-11-07	71	0
K951858	TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS	Medtronic Vascular	1995-10-12	174	0
K951950	PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING	Pacesetter, Inc.	1995-08-31	127	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