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

Adr Ultrasound — Predicate Candidate Screening

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

65 daysmedian FDA review time
121 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K840408LINEAR ARRAY TRANSDUCER OR SCANHEADAdr Ultrasound1984-04-25850
K834141ULTRASOUND SCAN HEAD 3.5 MHZAdr Ultrasound1984-04-201210
K833224BIFOCAL 3.0MHZAdr Ultrasound1983-11-29840
K828050ADR ULTRASOUND MODEL 4000 LAdr Ultrasound1982-09-29290
K828051ADR ULTRASOUND MODEL 4000 SC OR 4000 S/LCAdr Ultrasound1982-09-29290
K828049ADR ULTRASOUND MC2 LARGE CARTAdr Ultrasound1982-09-29290
K828053ADR ULTRASOUND 5.5 MHZ SHORT FOCUS TRANSDUCERAdr Ultrasound1982-09-29290
K813543ADR ULTRASOUND MODELS 4000S & 4000S/LAdr Ultrasound1982-02-24650
K812301VARIABLE FOCUS 3.5 MHZ TRANSDUCERAdr Ultrasound1981-11-16940
K792446ADR REAL-TIME SECTOR SCANNERAdr Ultrasound1980-01-09400

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