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

KRE — Predicate Candidate Screening

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

77 daysmedian FDA review time

283 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K110693	PACEART OPTIMA SYSTEM SOFTWARE	Medtronic, Inc.	2011-06-08	89
K072950	CYGNUS 12 LEAD ECG MODULE	Cygnus, LLC	2008-08-22	309
K032926	EKG SPEAKS	Medtronic Vascular	2003-10-15	23
K922742	HPM 40 HEART PACEMAKER MONITOR	Biotronik, GmbH & Co.	1993-03-18	283
K915632	PACEART CPTS-86/12	Paceart, Inc.	1992-04-14	119
K895535	PACEVIEW	Micromedical	1990-03-19	187
K870909	PACEMAKER FUNCTION ANALYZER	Paceart, Inc.	1987-04-27	53
K833647	PACEMAKER SYS ANALYZER #384	Pacesetter Systems	1983-12-16	60
K832959	PACEMAKER SYS. ANALYZER 378	Siemens Elema AB	1983-11-14	76
K803286	CARDIOMEMO	Instromedix, Inc.	1981-03-17	77
K800696	ELECTRONIC PACEMAKER WAVEFORM ANALYZER	Instromedix, Inc.	1980-08-14	139
K801022	ULTRA-CHEK PACEMAKER MONITOR	Powers Medical Systmes	1980-06-17	48
K800782	PACE-PULSE/COMPUTRAC	Bib, Inc.	1980-05-28	50

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