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

Cardiogenes — Predicate Candidate Screening

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

95 daysmedian FDA review time

291 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days
K961560	ECLIPSE 2000	Cardiogenes	1997-01-27	291
K955006	ECLIPSE 2100	Cardiogenes	1996-01-17	77
K952755	POWERSCULPTOR PROBES	Cardiogenes	1995-09-14	91
K953658	CORSSFIRE PLUS	Cardiogenes	1995-08-21	67
K953424	ECLIPSE 3200	Cardiogenes	1995-08-11	39
K945126	ECLIPSE 3200	Cardiogenes	1995-01-18	91
K944758	SUNRISE TECHNOLOGIES MODEL 5020 PLDD KIT	Cardiogenes	1994-12-27	95
K944153	ECLIPSE 3200	Cardiogenes	1994-11-09	90
K944151	OPTICAL FIBER FOR ENT APPLICATIONS	Cardiogenes	1994-11-01	84
K943171	CROSSFIRE(TM) (705-10650)	Cardiogenes	1994-09-20	96
K943311	ECLIPSE 3200	Cardiogenes	1994-07-22	15
K931305	ECLIPSE 3200 FOR USE IN UROLOGY APPLICATIONS	Cardiogenes	1994-01-07	298
K934935	ECLIPSE LAZERBLADE(TM) FIBEROPTIC DELIVERY SYSTEM	Cardiogenes	1993-11-22	46
K931101	ECLIPSE 2100(TM) MODEL 32, MODIFICATION	Cardiogenes	1993-08-25	198
K926210	ECLIPSE 3200	Cardiogenes	1993-07-28	230
K931306	ECLIPSE 3200 FOR USE IN ORTHO SURG/ARTH APPL JOINT	Cardiogenes	1993-07-23	130
K925840	ECLIPSE 3200	Cardiogenes	1993-06-25	227
K924943	ECLIPSE 3200(TM) HO:YAG LASER FOR PERCU DISKETOMY	Cardiogenes	1993-05-17	236
K924214	ECLIPSE 2100(TM) MODEL 32	Cardiogenes	1992-11-16	111
K921038	ECLIPSE 2100	Cardiogenes	1992-06-04	92

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