Atlas FDA

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

OEO — Predicate Candidate Screening

6 FDA 510(k) clearances under this product code; the 50 most recent screened below.

275 daysmedian FDA review time
412 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K142965Virtuoso System for IHC PR (1E2) using iScan HTVentana Medical Systems, Inc.2015-07-162750
K131140OMNYX IDP FOR HER2 MANUAL APPLICATIONOmnyx, LLC2014-04-013440
K130021PHILIPS HERCEPTEST DIGITAL SCOREPhilips Medical Systems Nederland B.V.2013-09-192590
K111914VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEMOlympus America Inc. / Scientific Equipment Group2012-08-214120
K080254SCANSCOPE XT SYSTEMAperio Technologies2008-10-312740
K071671SCANSCOPE XT SYSTEMAperio Technologies2007-12-281920

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