Atlas FDA

DTD

103 FDA 510(k) clearances · Product code

66 daysmedian time to decision
192 days90th percentile
103clearances measured

FDA profile

Official device name
Pacemaker Lead Adaptor
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3620
Medical specialty
Cardiovascular
Flags
Implant
Adverse events (MAUDE)
2021: 23 · 2022: 25 · 2023: 28 · 2024: 35 · 2025: 32 · 2026: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
IS4/DF4 Port Plug (K143463)Oscor, Inc.2015-03-19
6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP (K132008)Medtronic, Inc.2013-07-30
CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 (K041574)Guidant Corporation2004-07-12
PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV (K031164)Oscor, Inc.2003-06-19
PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR (K024156)Oscor, Inc.2003-01-14
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS (K010787)Oscor, Inc.2001-05-22
A1-CS-SB Y-ADAPTER, MODEL 124 871 (K003454)Biotronik, Inc.2001-01-18
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT (K000210)Medtronic Vascular2000-02-23
MODEL 2872 BIPOLAR LEAD ADAPTOR KIT (K982220)Medtronic Vascular1998-10-15
BK-N SEALING CAP (K971930)Biotronik, Inc.1997-08-14
A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE (K970388)Biotronik, Inc.1997-08-14
BK-A; BK-B; BK-IS SEALING CAP (K970204)Biotronik, Inc.1997-04-29
IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 (K950140)Pacesetter, Inc.1995-04-06
BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM (K934899)Telectronics Pacing Systems, Inc.1994-05-12
MISCELLANEOUS PACING LEAD (K925168)Oscor Medical Corp.1994-05-03
ADAPTING SLEEVE KIT MODEL 4023 (K921318)Siemens-Pacesetter, Inc.1992-08-03
MODEL 6984M LEAD EXTENDER KIT (K915724)Medtronic Vascular1992-02-18
UNIPOLAR UPSIZING ADAPTOR (K912773)Telectronics Pacing Systems, Inc.1991-10-23
LEAD TERMINAL PIN CAPS, VARIOUS MODELS (K911142)Biotronik, GmbH & Co.1991-08-09
MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT (K911302)Medtronic Vascular1991-07-30
MODEL 5866-9M & MODEL 6981M (K911827)Metronic, Inc.1991-07-23
MODEL 5857-3M LEAD END CAP KIT (K911048)Medtronic Vascular1991-04-18
MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT (K910630)Medtronic Vascular1991-04-18
BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR (K910112)Telectronics Pacing Systems, Inc.1991-02-25
MODEL 5866-37M LEAD ADAPTOR KIT (K904575)Medtronic Vascular1991-02-01
A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE. (K902889)Biotronik, GmbH & Co.1990-08-23
SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS (K900512)Pacesetter Systems1990-06-25
MODEL 5866-34 LEAD ADAPTOR KIT (K900627)Medtronic Vascular1990-04-20
UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER (K896438)Telectronics Pacing Systems, Inc.1990-04-10
3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100 (K900605)Possis Medical, Inc.1990-03-06
IMPLANTABLE ADAPTOR 033-380 (K890895)Telectronics, Inc.1990-03-06
TELECTRONICS PACING SYSTEMS VS-1 TO 6MM UPSIZING (K895971)Telectronics Pacing Systems, Inc.1990-02-22
ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP. (K894976)Medtronic Vascular1989-10-12
ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33 (K894718)Intermedics, Inc.1989-09-05
DAIG PACEMAKER LEAD ADAPTOR (K870562)Daig Corp.1987-03-03
PACEMAKER LEAD ADAPTER (K862656)Cordis Corp.1986-07-30
MODEL 366-08 ADAPTAID CONNECTOR ADAPTER (K860832)Intermedics, Inc.1986-03-31
IMPLANTABLE ELECTRODE ADAPTOR ASSEMBLY (K854997)Telectronics, Inc.1986-02-12
BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD (K844814)Intermedics, Inc.1985-08-29
MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN (K850968)Medtronic Vascular1985-08-29
CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD (K851897)Cardiac Control Systems, Inc.1985-08-09
MEDTRONIC MODEL 5561 (K852356)Medtronic Vascular1985-08-06
329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR (K852253)Cordis Corp.1985-07-29
MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD (K851457)Intermedics, Inc.1985-07-11
MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD (K851458)Intermedics, Inc.1985-07-11
MEDTRONIC 5064 (K851890)Medtronic Vascular1985-06-19
PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE (K851665)Pacesetter Systems1985-05-21
PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD (K851145)Pacesetter Systems1985-04-19
PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD (K850652)Pacesetter Systems1985-04-10
PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR (K850576)Pacesetter Systems1985-03-06
MEDTRONIC 5061 ENDOCARDIAL PACING LEAD (K844974)Medtronic Vascular1985-03-06
PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD (K844857)Pacesetter Systems1985-02-14
BIOTRONIK DNP UNIPOLAR (K841450)Biotronik Sales, Inc.1985-02-07
BIOTRONIK DY-UNIPOLAR (K841451)Biotronik Sales, Inc.1985-02-07
MEDTRONIC MODEL 6912 (K844687)Medtronic Vascular1985-02-01
EPICARDIAL, UNIPOLAR LEAD 4951 (K842065)Medtronic Vascular1985-01-18
TRANSVENOUS TINED VENTRICULAR LEAD (K842145)Medtronic Vascular1985-01-18
PERMATHANE 865 & 867 UNIPOLAR POLYURETH (K843703)Pacesetter Systems1985-01-08
BIPOLAR ENDOCARDIAL LEAD 406L (K841227)Siemens Elema AB1984-11-27
SENTRA (K843060)Cardiac Pacemakers, Inc.1984-09-20
MODEL 866 PERMATHANE BIPOLAR, COAXIAL (K841739)Pacesetter Systems1984-08-03
FASTPASS IMPLANTABLE ENDOCARDIAL PAC (K841885)Pacesetter Systems1984-08-03
IMPLANTABLE ELECTRODE UNIPOLAR ADAPT (K840026)Telectronics, Inc.1984-05-23
IMPLANTABLE ELECTRODE BIPOLAR ADAPT (K840025)Telectronics, Inc.1984-05-23
LEAD ADAPTERS #'S 6016,6022,6017 ETC (K831160)Cardiac Pacemakers, Inc.1983-05-09
MODEL 366-07 ADAPT AID LEAD ADAPTER (K822704)Intermedics, Inc.1982-11-24
PACEMAKER CONNECTOR PLUG (K821548)Pacesetter Systems1982-06-02
PACEMAKER 445 ADAPTER (K821549)Pacesetter Systems1982-06-02
PACEMAKER UNIPOLAR ADAPTER (K821547)Pacesetter Systems1982-06-02
MODEL 5866-26 LEAD ADAPTER KIT (K820935)Medtronic Vascular1982-04-16
ELECTRODE TERMINAL CAP (K813152)Pacesetter Systems1981-12-02
ADAPTING SLEEVE (K813154)Pacesetter Systems1981-12-02
VITATRON INSERT (K813151)Pacesetter Systems1981-12-02
ADAPTAID #365-38 (K812756)Intermedics, Inc.1981-10-29
INTERMEDICS ADAPTAID STEP-DOWN ADAPTER (K812812)Intermedics, Inc.1981-10-27
ADAPTAID LEAD ADAPTER, #365-17 (K811920)Intermedics, Inc.1981-08-13
ADAPTAID LEAD ADAPTER #365-25 (K811938)Intermedics, Inc.1981-08-07
MODEL 5866-24 LEAD ADAPTOR KIT (K811349)Medtronic Vascular1981-06-30
PACEMAKER LEAD ADAPTER (K810551)Pacesetter Systems1981-04-23
IMPLANTABLE PACEMAKER LEAD ADAPTER (K810245)Intermedics, Inc.1981-03-04
PACEMAKER LEAD ADAPTOR MODEL 431 (K802407)Pacesetter Systems1980-10-31
UNIPOLAR TO BIPOLAR PULSE GEN. ADAPTER (K802077)Cardiac Pacemakers, Inc.1980-10-23
ADAPTAID HELICAL COIL ADAPTER 365-14 (K801039)Intermedics, Inc.1980-07-21
ADAPTAID ELEMA LEAD ADAPTER KIT 365-17 (K801038)Intermedics, Inc.1980-07-08
GE LEAD ADAPTER, MODEL 345-01 (K801040)Intermedics, Inc.1980-06-30
ADAPTER KIT (K800353)Daig Corp.1980-05-28
BIPOLAR LEAD ADAPTOR, MODEL BA-415 (K790218)Pacesetter Systems1979-08-10
IMPLANTABLE HEART LEAD TERMINAL ADAPTER (K790436)Arco Medical Products Co.1979-05-14
IMPLANTABLE HEART LEAD EXTENDER (K790468)Arco Medical Products Co.1979-03-19
ELECTRODE, MODEL 030-326 (K781823)Telectronics, Inc.1979-02-08
ELECTRODE, MODEL 030-324 (K781822)Telectronics, Inc.1979-02-08
ELECTRODE, MODEL 030-324/4 GUAGE (K781824)Telectronics, Inc.1979-02-08
ELECTRODE LEAD MODEL 030-198 (K782097)Telectronics, Inc.1978-12-22
ADAPTER KIT (K781864)Daig Corp.1978-12-19
PACING LEAD ADAPTER MODEL ACS 16 (K781622)R.E. Brown Co., Inc.1978-12-08
PACING LEAD ADAPTER, ACV 14, ACV 23 (K781626)R.E. Brown Co., Inc.1978-12-08
PACING LEAD ADAPTER MODEL ADB 21 (K781627)R.E. Brown Co., Inc.1978-12-08
LEAD ADAPTOR KIT MODEL 5866-21 (K772058)Medtronic Vascular1977-11-03
ADAPTER A-413 (K771642)Pacesetter Systems1977-09-14
UNIVERSAL LEAD ADAPTER, UA-414 (K771641)Pacesetter Systems1977-09-14
Next →

Track DTD automatically

Every clearance here is in the API, with alerts when new ones post.