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

DTD — Predicate Candidate Screening

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

66 daysmedian FDA review time

192 days90th percentile

103clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K143463	IS4/DF4 Port Plug	Oscor, Inc.	2015-03-19	105	0
K132008	6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD	Medtronic, Inc.	2013-07-30	29	0
K041574	CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020	Guidant Corporation	2004-07-12	28	0
K031164	PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV	Oscor, Inc.	2003-06-19	66	0
K024156	PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPO	Oscor, Inc.	2003-01-14	28	0
K010787	PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS	Oscor, Inc.	2001-05-22	68	1
K003454	A1-CS-SB Y-ADAPTER, MODEL 124 871	Biotronik, Inc.	2001-01-18	72	0
K000210	MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT	Medtronic Vascular	2000-02-23	30	0
K982220	MODEL 2872 BIPOLAR LEAD ADAPTOR KIT	Medtronic Vascular	1998-10-15	113	0
K971930	BK-N SEALING CAP	Biotronik, Inc.	1997-08-14	79	0
K970388	A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE	Biotronik, Inc.	1997-08-14	192	0
K970204	BK-A; BK-B; BK-IS SEALING CAP	Biotronik, Inc.	1997-04-29	98	0
K950140	IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069	Pacesetter, Inc.	1995-04-06	83	0
K934899	BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM	Telectronics Pacing Systems, Inc.	1994-05-12	210	0
K925168	MISCELLANEOUS PACING LEAD	Oscor Medical Corp.	1994-05-03	567	0
K921318	ADAPTING SLEEVE KIT MODEL 4023	Siemens-Pacesetter, Inc.	1992-08-03	137	0
K915724	MODEL 6984M LEAD EXTENDER KIT	Medtronic Vascular	1992-02-18	60	0
K912773	UNIPOLAR UPSIZING ADAPTOR	Telectronics Pacing Systems, Inc.	1991-10-23	121	0
K911142	LEAD TERMINAL PIN CAPS, VARIOUS MODELS	Biotronik, GmbH & Co.	1991-08-09	148	0
K911302	MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT	Medtronic Vascular	1991-07-30	127	0
K911827	MODEL 5866-9M & MODEL 6981M	Metronic, Inc.	1991-07-23	90	0
K911048	MODEL 5857-3M LEAD END CAP KIT	Medtronic Vascular	1991-04-18	41	0
K910630	MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT	Medtronic Vascular	1991-04-18	64	0
K910112	BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR	Telectronics Pacing Systems, Inc.	1991-02-25	46	0
K904575	MODEL 5866-37M LEAD ADAPTOR KIT	Medtronic Vascular	1991-02-01	115	0
K902889	A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.	Biotronik, GmbH & Co.	1990-08-23	52	0
K900512	SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS	Pacesetter Systems	1990-06-25	143	0
K900627	MODEL 5866-34 LEAD ADAPTOR KIT	Medtronic Vascular	1990-04-20	71	0
K896438	UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER	Telectronics Pacing Systems, Inc.	1990-04-10	152	0
K900605	3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100	Possis Medical, Inc.	1990-03-06	26	0
K890895	IMPLANTABLE ADAPTOR 033-380	Telectronics, Inc.	1990-03-06	377	0
K895971	TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING	Telectronics Pacing Systems, Inc.	1990-02-22	132	0
K894976	ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP.	Medtronic Vascular	1989-10-12	66	0
K894718	ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33	Intermedics, Inc.	1989-09-05	42	0
K870562	DAIG PACEMAKER LEAD ADAPTOR	Daig Corp.	1987-03-03	21	2
K862656	PACEMAKER LEAD ADAPTER	Cordis Corp.	1986-07-30	16	0
K860832	MODEL 366-08 ADAPTAID CONNECTOR ADAPTER	Intermedics, Inc.	1986-03-31	26	0
K854997	IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY	Telectronics, Inc.	1986-02-12	62	0
K844814	BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD	Intermedics, Inc.	1985-08-29	261	0
K850968	MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN	Medtronic Vascular	1985-08-29	174	0
K851897	CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD	Cardiac Control Systems, Inc.	1985-08-09	101	0
K852356	MEDTRONIC MODEL 5561	Medtronic Vascular	1985-08-06	64	0
K852253	329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR	Cordis Corp.	1985-07-29	66	0
K851457	MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD	Intermedics, Inc.	1985-07-11	91	0
K851458	MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD	Intermedics, Inc.	1985-07-11	91	0
K851890	MEDTRONIC 5064	Medtronic Vascular	1985-06-19	50	0
K851665	PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE	Pacesetter Systems	1985-05-21	29	0
K851145	PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD	Pacesetter Systems	1985-04-19	29	0
K850652	PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD	Pacesetter Systems	1985-04-10	50	0
K850576	PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR	Pacesetter Systems	1985-03-06	21	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