Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

DTC — Predicate Candidate Screening

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

84 daysmedian FDA review time

295 days90th percentile

30clearances measured

K-number	Device	Applicant	Decided	Review days
K170815	PSA Cable	Boston Scientific Corporation	2017-07-06	111
K083674	PK-141 PATIENT CABLE	Biotronik, Inc.	2009-04-01	111
K011729	SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000	Dni Nevada, Inc.	2001-08-30	87
K002497	MODEL 4810 ANALYZER OUTPUT ADAPTER	Pace Medical	2000-10-10	57
K961582	EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100	North American Technical Services Corp.	1996-11-08	198
K903966	EXTERNAL PACEMAKER ANALYZER MODEL PMA-1	Bio-Tek Instruments, Inc.	1991-06-19	295
K910595	MODEL 5311B A-V PACING SYSTEM ANALYZER	Medtronic Vascular	1991-05-07	84
K910223	CPI MODEL 2215/SEAMED MODEL 3400	Seamed Corp.	1991-03-19	60
K901332	PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE	Biotronik, GmbH & Co.	1990-05-09	48
K896632	MEDTRONIC MODEL 5401B TEST CABLE	Medtronic Vascular	1989-12-13	21
K884331	MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER	Medtronic Vascular	1989-01-10	88
K882327	PACER SENSING ANALYZER (PSA 100)	Oscor Medical Corp.	1988-10-06	122
K860462	SEAMED MODEL 3000	Seamed Corp.	1986-08-19	194
K851900	SEA MED DDD PACING SYSTEM ANALYZER	Seamed Corp.	1985-07-19	80
K850077	MEDTRONIC 5311 PACING SYSTEM ANALYZER	Medtronic Vascular	1985-07-16	188
K844969	CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)	Cordis Corp.	1985-05-01	128
K831697	TELECTRONICS MODEL 2401	Seamed Corp.	1984-09-04	468
K812262	MEDTRONIC A-V PACING SYSTEM ANALYZER	Medtronic Vascular	1982-06-17	308
K810604	ELECTRODE/PACER SYSTEM ANALYZER PMA 400	Telectronics, Inc.	1981-04-14	39
K792602	SUSI II PACEMAKER SURVEILLANCE MONITOR	Ela Medical, Inc.	1980-03-25	98
K800286	CRITERION II PACING SYSTEM MONITORS	Dart Medical Equipment	1980-03-12	33
K791975	PACING SYSTEM ANALYZER PSA SCE-22	Ela Medical, Inc.	1980-01-31	121
K792074	MODEL 674 PACER ANALYZER	Del Mar Avionics	1979-12-27	73
K791762	SELF CHECK	Instromedix, Inc.	1979-09-21	24
K781349	PACER-TRACER PULSE WIDTH	Instromedix, Inc.	1978-08-31	24
K781144	ANALYZER, PACER SYSTEM, PSA-5	Edwards Pacemaker Systems	1978-08-23	44
K780717	EXTERNAL TEST PULSE GENERATOR	Vitatron Medical BV	1978-06-30	64
K771922	MINICLINIC TM	Instromedix, Inc.	1977-11-02	20
K770865	MONITOR, PACEMAKER	Adcor Electronics, Inc.	1977-06-14	34
K760013	PACER SYSTEMS ANALYZER (CORDIS)	Cordis Corp.	1976-07-20	40

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