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

Endosonics Corp. — Predicate Candidate Screening

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

106 daysmedian FDA review time
350 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K000820AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MEndosonics Corp.2000-06-05840
K990271ENDOSONICS TRAK BACK DEVICEEndosonics Corp.1999-08-302140
K982329VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)Endosonics Corp.1999-01-141960
K965223RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASEndosonics Corp.1998-06-295450
K963290COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASEndosonics Corp.1997-08-063500
K962293ENDOSONICS AUTOMATIC PULL BACK DEVICEEndosonics Corp.1996-09-16940
K950276MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTEndosonics Corp.1995-09-222420
K944004VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300)Endosonics Corp.1995-05-042610
K926252CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SYEndosonics Corp.1993-10-253150
K924980CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATHEndosonics Corp.1993-01-151060
K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.1991-06-25890
K902454CATHSCANNER(R) PTA BALLOON DILATATION CATHETEREndosonics Corp.1990-08-30900
K894747PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH.Endosonics Corp.1989-10-12780
K893042CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEMEndosonics Corp.1989-07-19860
K890492PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH.Endosonics Corp.1989-03-02300

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