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

Intermedics, Inc. — Predicate Candidate Screening

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

55 daysmedian FDA review time

197 days90th percentile

211clearances measured

K-number	Device	Applicant	Decided	Review days
K954610	MODEL 430-07 ENDOCARDIAL PACING LEAD	Intermedics, Inc.	1996-12-16	439
K955122	INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMP	Intermedics, Inc.	1996-11-04	361
K962174	BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 0	Intermedics, Inc.	1996-08-21	77
K955550	CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD	Intermedics, Inc.	1996-06-19	197
K960281	IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTAB	Intermedics, Inc.	1996-06-18	151
K954719	INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PAC	Intermedics, Inc.	1996-02-27	137
K933278	INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04	Intermedics, Inc.	1995-03-15	624
K922042	CARDIFIX ENDOCARDIAL PACING LEAD	Intermedics, Inc.	1993-04-29	363
K922972	MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD	Intermedics, Inc.	1993-01-22	217
K920530	INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG	Intermedics, Inc.	1992-03-17	41
K912235	MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD	Intermedics, Inc.	1991-09-18	127
K911122	8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS	Intermedics, Inc.	1991-05-16	65
K903948	INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD	Intermedics, Inc.	1991-04-22	238
K902672	INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD	Intermedics, Inc.	1991-03-01	256
K894718	ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33	Intermedics, Inc.	1989-09-05	42
K890411	MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS	Intermedics, Inc.	1989-03-28	63
K890412	MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS	Intermedics, Inc.	1989-03-28	63
K883602	BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD	Intermedics, Inc.	1988-09-06	14
K875178	MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD	Intermedics, Inc.	1988-05-25	160
K875100	MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD	Intermedics, Inc.	1988-05-24	166
K872126	MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD	Intermedics, Inc.	1988-03-22	294
K880551	MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD	Intermedics, Inc.	1988-03-07	27
K874531	POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD	Intermedics, Inc.	1988-01-07	65
K874930	MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER	Intermedics, Inc.	1988-01-06	35
K873921	MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE	Intermedics, Inc.	1987-12-03	69
K874394	QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.	Intermedics, Inc.	1987-11-23	26
K873528	MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS	Intermedics, Inc.	1987-10-09	38
K872230	MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE	Intermedics, Inc.	1987-09-15	98
K871580	IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01	Intermedics, Inc.	1987-05-22	29
K871625	MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER	Intermedics, Inc.	1987-05-21	24
K870357	ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY	Intermedics, Inc.	1987-05-21	112
K870948	MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD	Intermedics, Inc.	1987-04-10	32
K864326	MODEL 366-13 ADAPTAID STEP DOWN ADAPTER	Intermedics, Inc.	1987-01-16	73
K862051	MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD	Intermedics, Inc.	1987-01-06	222
K864738	MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP	Intermedics, Inc.	1987-01-06	33
K864428	MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER	Intermedics, Inc.	1986-12-05	23
K864564	MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD	Intermedics, Inc.	1986-12-05	16
K864287	MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD	Intermedics, Inc.	1986-11-20	21
K864002	MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD	Intermedics, Inc.	1986-11-20	37
K863781	MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD	Intermedics, Inc.	1986-11-03	38
K864048	MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER	Intermedics, Inc.	1986-11-03	17
K864047	MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER	Intermedics, Inc.	1986-11-03	18
K863418	MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE	Intermedics, Inc.	1986-09-24	21
K862054	MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD	Intermedics, Inc.	1986-09-19	113
K862053	MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD	Intermedics, Inc.	1986-09-19	113
K862257	MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD	Intermedics, Inc.	1986-07-10	27
K862258	MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD	Intermedics, Inc.	1986-07-10	27
K862259	MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD	Intermedics, Inc.	1986-07-10	27
K862052	MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD	Intermedics, Inc.	1986-07-03	35
K862276	MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD	Intermedics, Inc.	1986-07-02	16

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