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

Medasonics, Inc. · Predicate Candidate Screening

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

59 daysmedian FDA review time
246 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K991441CADENCE DOPPLER ULTRASOUND SYSTEMMedasonics, Inc.1999-12-282460
K962796NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEMMedasonics, Inc.1997-01-211870
K961116FIRST BEAT/CARDIO BEAT/CALCMedasonics, Inc.1996-08-081410
K914862CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDSMedasonics, Inc.1992-12-034010
K911453OBTRASOUND STETHOSCOPE FETAL CALCMedasonics, Inc.1991-06-20780
K882018MEDACORD PVL, PERSONAL VASCULAR LABORATORYMedasonics, Inc.1988-09-211310
K872292TRANSPECT TRANSCRANIAL DOPPLERMedasonics, Inc.1987-08-14590
K854734MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLEMedasonics, Inc.1986-02-10770
K833588VASCULAR LABORATORY TREADMILL VT1Medasonics, Inc.1983-11-14330
K837481BF24 DOPPLER MODEL P872 AND P874Medasonics, Inc.1983-06-24460
K831393VASCULAB BLOOD PRESSURE CUFFMedasonics, Inc.1983-06-16480
K820898VASCULAB SPECTRUM ANALYZER #SP25Medasonics, Inc.1982-04-21220
K812608VASCULAB #R12BMedasonics, Inc.1981-10-02170
K812609VASCULAB #VSC21Medasonics, Inc.1981-10-02170
K801549MODEL R11 SINGLE CHANNEL CHART RECORDERMedasonics, Inc.1980-07-1470
K800768VASCULAB BI-DIRECTIONAL DOPPLER, #D10Medasonics, Inc.1980-07-08920
K800767MOD. MCI 17 MANUAL CUFF INFLATORMedasonics, Inc.1980-04-24170
K782132PLETHYSMOGRAPH, STRAIN GAUGEMedasonics, Inc.1979-02-26610
K781358SEQUENTIAL CUFF INFLATION DEVICEMedasonics, Inc.1978-09-20430

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