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

American Pacemaker Corp. — Predicate Candidate Screening

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

86 daysmedian FDA review time

217 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K821791	EXTERNAL PULSE GENERATOR - EV4542	American Pacemaker Corp.	1982-07-06	19
K812830	APC IMPLANTABLE PACING LEAD	American Pacemaker Corp.	1982-01-18	102
K812807	APC IMPLANTABLE PACING LEADS	American Pacemaker Corp.	1982-01-18	104
K810399	APC IMPLANTABEL PACING LEAD, MODEL 3264	American Pacemaker Corp.	1981-05-15	86
K810397	APC IMPLANTABLE PACING LEAD-FLANGE #3260	American Pacemaker Corp.	1981-05-15	86
K810398	APC IMPLANTABLE PACING LEAD, MODEL 3266	American Pacemaker Corp.	1981-05-15	86
K810396	APC IMPLANTABLE PACING LEAD, TINED #3262	American Pacemaker Corp.	1981-05-15	86
K810121	UNIFOCAL 3	American Pacemaker Corp.	1981-02-23	35
K800746	UNIFOCAL VP, MODELS 7501 AND 7502	American Pacemaker Corp.	1980-12-16	257
K800379	BIFOCAL 2 8200 SERIES (A,B C,D)	American Pacemaker Corp.	1980-09-26	217
K792199	UNIFOCAL 2-UNIPOLAR & BIPOLAR	American Pacemaker Corp.	1979-11-27	26
K792232	UNIFOCAL 3-2 MODELS UNIPOLAR & BIPOLAR	American Pacemaker Corp.	1979-11-27	22
K791955	UNIFOCAL 1 UNIPOLAR DEMAND R WAVE	American Pacemaker Corp.	1979-11-27	57
K770328	PACEMAKER, ANTRIO-VENTRICULAR SEQ.	American Pacemaker Corp.	1977-02-28	11

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