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

Cook Pacemaker Corp. — Predicate Candidate Screening

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

33 daysmedian FDA review time

113 days90th percentile

34clearances measured

K-number	Device	Applicant	Decided	Review days
K970690	LOCKING STYLET 2	Cook Pacemaker Corp.	1997-05-20	84
K961992	NEEDLE'S EYE SNARE	Cook Pacemaker Corp.	1996-12-27	220
K953417	MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS	Cook Pacemaker Corp.	1995-09-29	113
K915188	MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD	Cook Pacemaker Corp.	1992-09-11	298
K905403	MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER	Cook Pacemaker Corp.	1991-10-16	317
K863582	MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)	Cook Pacemaker Corp.	1986-10-08	23
K861559	SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS	Cook Pacemaker Corp.	1986-05-09	14
K860466	MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.	Cook Pacemaker Corp.	1986-02-24	18
K860202	MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.	Cook Pacemaker Corp.	1986-02-24	33
K854919	BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY	Cook Pacemaker Corp.	1985-12-19	10
K854132	COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS	Cook Pacemaker Corp.	1985-12-03	54
K853590	COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI	Cook Pacemaker Corp.	1985-10-23	56
K853651	COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER	Cook Pacemaker Corp.	1985-10-23	50
K851699	COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE	Cook Pacemaker Corp.	1985-05-16	22
K850656	COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM	Cook Pacemaker Corp.	1985-03-01	10
K843001	COOK PACEMAKER CORP. 116 BIOPOLAR CARDI	Cook Pacemaker Corp.	1984-07-30	0
K841983	COOK PACEMAKER 216 BIPOLAR CARDIAC -	Cook Pacemaker Corp.	1984-07-11	57
K841928	COOK PACEMAKER 215 UNIPOLAR CARDIAC-	Cook Pacemaker Corp.	1984-07-11	62
K842081	COOK PACEMAKER CORP. 115 UNIPOLAR CARDI	Cook Pacemaker Corp.	1984-07-06	44
K832893	MODEL 329T PROGRAMMABLE, BIPOLAR CARDI	Cook Pacemaker Corp.	1983-10-04	39
K832245	UNIPOLAR-E ENDOCARDIAL TINED LEAD	Cook Pacemaker Corp.	1983-08-12	32
K832255	MODEL F UNIPOLAR ENDOCARDIAL LEAD-	Cook Pacemaker Corp.	1983-08-12	32
K832052	MODEL 327T UNIPOLAR CARDIAC PULSE GEN	Cook Pacemaker Corp.	1983-08-08	42
K822904	MODEL 325D UNIPOLAR CARDIAC PULSE GEN	Cook Pacemaker Corp.	1982-10-15	16
K822652	JAIN INSULATING BOOT MODEL 225B	Cook Pacemaker Corp.	1982-10-04	32
K821147	COOK #326T PROGRAM/TELEMETRY BIPOLAR	Cook Pacemaker Corp.	1982-05-07	14
K812832	MODEL 325C UNIPOLAR CARDIAC PULSE GEN.	Cook Pacemaker Corp.	1981-11-05	27
K812358	MODEL 325T PROGRAMMABLE PULSE GENERATOR	Cook Pacemaker Corp.	1981-10-29	70
K811879	MODEL A UNIPOLAR ENDOCARDIAL LEAD	Cook Pacemaker Corp.	1981-08-03	33
K811877	MODEL C UNIPOLAR ENDOCARDIAL LEAD	Cook Pacemaker Corp.	1981-08-03	33
K811876	MODEL D BIPOLAR ENDOCARDIAL LEAD	Cook Pacemaker Corp.	1981-08-03	33
K811878	MODEL B BIPOLAR ENDOCARDIAL LEAD	Cook Pacemaker Corp.	1981-08-03	33
K810885	#326 PROGRAMMABLE CARD. PULSE GENERATOR	Cook Pacemaker Corp.	1981-06-16	76
K810884	#325 PROGRAMMABLE CARD. PULSE GENERATOR	Cook Pacemaker Corp.	1981-06-16	76

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