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

Advanced Medical Optics, Inc. · Predicate Candidate Screening

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

113 daysmedian FDA review time
311 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K081681VITRECTOMY CUTTER AND ACCESSORIESAdvanced Medical Optics, Inc.2008-10-081131
K081545ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30Advanced Medical Optics, Inc.2008-10-021220
K060366THE AMO OPHTHALMIC SURGICAL SYSTEMAdvanced Medical Optics, Inc.2006-04-07531
K042562LENS PLUS REWETTING DROPSAdvanced Medical Optics, Inc.2005-07-293110
K050648SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PAAdvanced Medical Optics, Inc.2005-04-05220
K040839COMPLETE BLINK-N-CLEAN LENS DROPSAdvanced Medical Optics, Inc.2004-10-192020
K032030BLINK CL LUBRICANT EYE DROPSAdvanced Medical Optics, Inc.2003-09-25860
K030092COMPLETE BRAND MULTI-PURPOSE SOLUTIONAdvanced Medical Optics, Inc.2003-04-04840

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