Atlas FDA

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

Advanced Medical Technology, Inc. · Predicate Candidate Screening

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

35 daysmedian FDA review time
315 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K083626DISTRACTABLE WAVE CAGEAdvanced Medical Technology, Inc.2009-10-193150
K874571PATIENTWATCH (TM)Advanced Medical Technology, Inc.1988-01-29850
K862777MODEL A-8000 ULTRASONIC HANDPIECE CORDAdvanced Medical Technology, Inc.1986-08-11200
K854225ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYSAdvanced Medical Technology, Inc.1985-12-27700
K852997RAPI - STAPHAdvanced Medical Technology, Inc.1985-08-19350
K853081AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SETAdvanced Medical Technology, Inc.1985-08-13210
K853187ACRIDINE ORANGE FLUORESCENT STAINAdvanced Medical Technology, Inc.1985-08-13140

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