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Pacesetter Systems — Predicate Candidate Screening

96 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

62 daysmedian FDA review time

162 days90th percentile

96clearances measured

K-number	Device	Applicant	Decided	Review days
K910924	ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE	Pacesetter Systems	1991-08-28	176
K902147	ENDOCARDIAL SCREW-IN LEAD MODEL 1028T	Pacesetter Systems	1990-07-17	63
K900512	SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS	Pacesetter Systems	1990-06-25	143
K900550	FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T	Pacesetter Systems	1990-04-20	73
K895447	ENDOCARDIAL SCREW-IN LEAD MODEL 1020T	Pacesetter Systems	1989-12-20	103
K891905	CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE	Pacesetter Systems	1989-06-05	70
K885267	VS-1 MODEL NUMBER 251K PULSE GENERATOR	Pacesetter Systems	1989-03-28	96
K890547	SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS	Pacesetter Systems	1989-03-22	47
K884733	AFP MODEL 262T PULSE GENERATOR	Pacesetter Systems	1989-02-10	92
K883087	PROLOG MP 658M PULSE GENERATOR	Pacesetter Systems	1988-09-14	55
K874205	ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T	Pacesetter Systems	1988-02-02	110
K872779	PROLOG MP PULSE GENERATORS 658K AND 658T	Pacesetter Systems	1987-11-04	113
K873931	MODIFIED MODELS 1025M & 1026T PACING LEAD	Pacesetter Systems	1987-10-22	38
K871208	UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M	Pacesetter Systems	1987-06-05	72
K870824	ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035	Pacesetter Systems	1987-03-20	66
K862226	DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS	Pacesetter Systems	1987-02-03	237
K861422	PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY	Pacesetter Systems	1986-06-26	71
K861436	SOF SET, MODELS 111 AND 112	Pacesetter Systems	1986-06-09	53
K861481	ENDOCARDIAL CARBON-TIP LEAD	Pacesetter Systems	1986-06-06	45
K860857	SOF SET, MODELS 113 AND 114	Pacesetter Systems	1986-05-27	81
K861464	LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS	Pacesetter Systems	1986-05-19	28
K861440	LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO	Pacesetter Systems	1986-05-13	26
K861140	PROGRAMALITH III PULSE GENERATOR	Pacesetter Systems	1986-05-02	37
K860546	DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37	Pacesetter Systems	1986-04-23	69
K855081	PHOENIX MODELS 250/251 PULSE GENERATORS	Pacesetter Systems	1986-03-07	78
K854195	PROGRAMALITH III MODELS 238 & 239	Pacesetter Systems	1986-01-07	84
K854405	PACESETTER SYSTEMS ENDOCARDIAL SMALL FIN LEAD	Pacesetter Systems	1985-12-04	33
K854220	PACESETTER SYSEMS ENDOCARDIAL TRI-FIX LEAD	Pacesetter Systems	1985-12-04	47
K853914	PACESETTER SYS FAST PASS ENDOCARDIAL LEAD 856 INLI	Pacesetter Systems	1985-12-03	71
K851665	PACESETTER SYSTEMS, MODEL 458 ADAPTER SLEEVE	Pacesetter Systems	1985-05-21	29
K851861	PROGRAMALITH III MODEL 249 PULSE GENERATOR	Pacesetter Systems	1985-05-16	20
K850464	PROGRAMALITH III 240 PULSE GENERATOR	Pacesetter Systems	1985-05-15	97
K851145	PACESETTER SYSTEMS INC. ENDOCARDIAL FINNED LEAD	Pacesetter Systems	1985-04-19	29
K850652	PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD	Pacesetter Systems	1985-04-10	50
K850651	PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR	Pacesetter Systems	1985-04-01	41
K850576	PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR	Pacesetter Systems	1985-03-06	21
K844857	PACESETTER SYSTEMS, INC. ENDOCARDIAL SCREW-IN LEAD	Pacesetter Systems	1985-02-14	62
K844851	MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504	Pacesetter Systems	1985-01-22	40
K844792	MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A	Pacesetter Systems	1985-01-22	43
K844334	VIVALITH II 301 PULSE GENERATOR	Pacesetter Systems	1985-01-10	64
K843703	PERMATHANE 865 & 867 UNIPOLAR POLYURETH	Pacesetter Systems	1985-01-08	109
K841739	MODEL 866 PERMATHANE BIPOLAR, COAXIAL	Pacesetter Systems	1984-08-03	98
K841885	FASTPASS IMPLANTABLE ENDOCARDIAL PAC	Pacesetter Systems	1984-08-03	88
K834431	PACING ELECTRODE	Pacesetter Systems	1984-03-12	87
K830016	VASCUTEK VASCULAR PROTHESIS VP1200K/50K	Pacesetter Systems	1983-12-21	352
K833647	PACEMAKER SYS ANALYZER #384	Pacesetter Systems	1983-12-16	60
K833824	ENDOCARDIAL SCREW-IN LEAD 859 & 861	Pacesetter Systems	1983-12-01	31
K832987	PERMANTHANE #866 BIPOLAR COAXIAL	Pacesetter Systems	1983-10-20	49
K831445	INFUSION SETS #'S 124 & 142 PERSONAL	Pacesetter Systems	1983-09-12	130
K831444	SINGLE USE SYRINGE #103 PERSONAL MEDIC	Pacesetter Systems	1983-09-12	130

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