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

KRG — Predicate Candidate Screening

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

77 daysmedian FDA review time

302 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days
K933278	INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04	Intermedics, Inc.	1995-03-15	624
K884522	MODEL 5650 OPTIMATE PERSONAL PROGRAMMER	Teletronics, Inc.	1989-08-25	302
K880738	MODEL 2331T PATIENT PROGRAMMER	Medtronic Vascular	1988-11-17	267
K882429	MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004	Tpl-Cordis, Inc.	1988-07-22	38
K864712	MODEL 1740 PERSONAL POCKET PROGRAMMER	Telectronics, Inc.	1987-12-17	379
K871986	MODEL 5600B PROGRAMMER, PACEMAKER	Telectronics, Inc.	1987-06-24	33
K863046	ULTRA SOFTWARE MODULE: MODEL 2016	Cardiac Pacemakers, Inc.	1986-12-05	115
K863045	PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580	Cardiac Pacemakers, Inc.	1986-09-29	48
K860584	SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN	Cardiac Pacemakers, Inc.	1986-06-06	108
K860546	DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37	Pacesetter Systems	1986-04-23	69
K844484	HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA	Vitatron Medical BV	1985-07-24	247
K844485	CERYX6, 611, CERYX 3 311 & CERYX 1 111	Vitatron Medical BV	1985-04-19	151
K844483	TP 1	Vitatron Medical BV	1985-04-19	151
K842364	HANDHELD PACEMAKER PROGRAMMER & SOFTWAR	Cardiac Pacemakers, Inc.	1984-09-24	98
K820230	PACEMAKER PROGRAMMER 2030	Cardiac Pacemakers, Inc.	1982-03-15	46
K812761	FLOW-DIRECTED BALLOON THERMODILUTION	Nova Medical Specialties	1981-11-02	32
K812813	INTERMEDICS PROGRAMMER, MODEL 522-03	Intermedics, Inc.	1981-10-27	21
K811217	PACEMAKER PROGRAMMER #2010	Cardiac Pacemakers, Inc.	1981-07-20	77
K810552	CORDIS PACEMAKER PROGRAMMERS 255A & 256A	Cordis Corp.	1981-03-20	18
K800376	EPR-200 PROGRAMMER MODEL 010	Biotronik Sales, Inc.	1980-04-21	60
K792580	PACEMAKER PROGRAMMER	Cardiac Pacemakers, Inc.	1979-12-19	5
K791419	OMNICOR PROGRAMMER MODEL 222C	Cordis Corp.	1979-11-27	133
K790220	PACEMAKER PROGRAMMER	Intermedics, Inc.	1979-07-31	182
K780175	RATE PROGRAMMER MODEL 520	Intermedics, Inc.	1978-04-21	77
K771855	OMNICOR PROGRAMMER MODEL 222A	Cordis Corp.	1977-10-07	9

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