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

DXY — Predicate Candidate Screening

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

56 daysmedian FDA review time

175 days90th percentile

461clearances measured

K-number	Device	Applicant	Decided	Review days
K993434	PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PI	Biotronik, Inc.	1999-11-10	29
K970072	OPUS S MODEL 4121 AND 4124 PACEMAKERS	Ela Medical, Inc.	1997-08-29	233
K945627	PIKOS LP 01, PIKOS LP E01	Biotronik, Inc.	1996-03-04	474
K953866	MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)	Medtronic Vascular	1995-12-15	127
K954092	ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTO	Medtronic Vascular	1995-12-15	127
K953417	MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS	Cook Pacemaker Corp.	1995-09-29	113
K952328	NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01	Biotronik, Inc.	1995-09-29	134
K952364	OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)	Ela Medical, Inc.	1995-09-01	123
K940039	PELLETHANE 75D	Medtronic Vascular	1995-07-12	554
K950751	TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECT	Medtronic Vascular	1995-05-15	87
K946188	CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER	Cardiac Control Systems, Inc.	1995-05-15	146
K950210	CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACE	Cardiac Control Systems, Inc.	1995-05-03	104
K941937	PIKOS E 01-B	Biotronik, Inc.	1994-08-30	131
K932884	MINIX/MINIX ST PULSE GENERATORS	Medtronic Vascular	1994-05-02	322
K923026	PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER	Biotronik, GmbH & Co.	1993-08-19	422
K923868	CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER	Cardiac Control Systems, Inc.	1993-05-14	284
K930770	MEDTRONIC MINIX & MINIX ST PULSE GENERATORS	Medtronic Vascular	1993-05-14	87
K920601	ASTRA T2, ASTRA T4, ASTRA T6	Cardiac Pacemakers, Inc.	1992-10-28	260
K920530	INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG	Intermedics, Inc.	1992-03-17	41
K920157	SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER	Schneider Intl., Ltd.	1992-03-16	62
K914109	PIKOS 01 & PIKOS E 01	Biotronik, GmbH & Co.	1992-02-26	166
K905403	MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER	Cook Pacemaker Corp.	1991-10-16	317
K913134	MODEL 4220	Pace Medical	1991-08-22	37
K912545	MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE	Pace Medical	1991-07-26	46
K911122	8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS	Intermedics, Inc.	1991-05-16	65
K905824	MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE	Cardiac Control Systems, Inc.	1991-05-16	136
K905087	TRIOS 02	Biotronik, GmbH & Co.	1991-05-07	175
K903186	OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE	Telectronics Pacing Systems, Inc.	1991-01-18	183
K904941	MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE	Cardiac Control Systems, Inc.	1991-01-03	63
K904602	MEDTRONIC MODEL 5301B TEST CABLE	Medtronic Vascular	1991-01-03	85
K904892	VACUUM BAKE CYCLE	Medtronic Vascular	1990-12-20	51
K903919	IMPLANTABLE PULSE DEVICES	Medtronic Vascular	1990-10-23	60
K903081	NEOS (TM) 02 B PULSE GENERATOR	Biotronik, GmbH & Co.	1990-09-14	64
K901535	MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.	Medtronic Vascular	1990-07-03	92
K902134	MINIX, MINIX ST, NEW IC: L74	Medtronic Vascular	1990-07-03	54
K900622	MODIFIED MODEL 5401B TEST CABLE	Medtronic Vascular	1990-04-26	77
K900461	OPUS MODEL 4021, VVI, 5MM UNIPOLAR	Ela Medical, Inc.	1990-03-14	42
K897116	OPTIMA MPT MODEL 5281E AND MODEL 5282E	Telectronics Pacing Systems, Inc.	1990-03-14	78
K896809	MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR	Medtronic Vascular	1990-01-26	53
K896184	KALOS 05 PULSE GENERATOR	Biotronik Cardiac Pacemakers	1990-01-18	85
K894239	NANOS	Biotronik Cardiac Pacemakers	1989-11-01	134
K894240	NEOS 02	Biotronik Cardiac Pacemakers	1989-10-26	128
K894494	LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD	Biotronik, GmbH & Co.	1989-10-17	90
K894065	OPUS MODEL 4001	Ela Medical, Inc.	1989-09-26	110
K895495	ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS	Medtronic Vascular	1989-09-26	29
K894267	OPUS MODELS 4033 AND 4034	Ela Medical, Inc.	1989-09-20	90
K891231	OPTIMA MPT AND SPT PACEMAKERS	Telectronics, Inc.	1989-09-12	189
K894055	MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS	Medtronic Vascular	1989-08-25	79
K884420	HOME BLOOD PRESSURE KIT, ANEROID	Yamasu Co. , Ltd.	1989-08-25	309
K894185	OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR	Telectronics Pacing Systems, Inc.	1989-08-17	62

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