Atlas FDA

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

Aperio Technologies — Predicate Candidate Screening

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

217 daysmedian FDA review time
533 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K080564SCANSCOPE XT SYSTEMAperio Technologies2009-08-145330
K080254SCANSCOPE XT SYSTEMAperio Technologies2008-10-312740
K073677SCANSCOPE XT SYSTEMAperio Technologies2008-08-012170
K071671SCANSCOPE XT SYSTEMAperio Technologies2007-12-281920
K071128SCANSCOPE XT SYSTEMAperio Technologies2007-10-101700

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