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

Diagnostic Ultrasound Corp. · Predicate Candidate Screening

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

97 daysmedian FDA review time
286 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K030763DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEMDiagnostic Ultrasound Corp.2003-03-26151
K022153BLADDERSCAN BVI 6100Diagnostic Ultrasound Corp.2002-08-15441
K982568BLADDERMANAGER PCI 5000 MODEL 1002Diagnostic Ultrasound Corp.1999-01-251860
K963585BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000Diagnostic Ultrasound Corp.1996-10-01220
K955840BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000Diagnostic Ultrasound Corp.1996-05-241500
K955942BLADDERSCAN BVI 5000Diagnostic Ultrasound Corp.1996-03-15800
K920664DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSIONDiagnostic Ultrasound Corp.1993-12-236790
K915342UD 2000 VIDEO OPTIONDiagnostic Ultrasound Corp.1992-06-101970
K915436BLADDERSCAN BVI 2500Diagnostic Ultrasound Corp.1992-03-03900
K911166DIAGNOSTIC ULTRASOUND/URO-GYN UD 511Diagnostic Ultrasound Corp.1991-08-151530
K911125DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020Diagnostic Ultrasound Corp.1991-08-151550
K911091DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIESDiagnostic Ultrasound Corp.1991-06-10900
K904792DIAGNOSTIC ULTRASOUND VERSADOPP 1000Diagnostic Ultrasound Corp.1991-01-28970
K902692DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002Diagnostic Ultrasound Corp.1990-09-13860
K902408DIAGNOSTIC ULTRASOUND UFS 1005Diagnostic Ultrasound Corp.1990-08-10710
K842539DIAGNOSTIC ULTRASOUND 105 & 110Diagnostic Ultrasound Corp.1985-04-102860

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