Atlas FDA

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

SEKISUI Diagnostics, LLC — Predicate Candidate Screening

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

190 daysmedian FDA review time
354 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemSEKISUI Diagnostics, LLC2025-04-183540
K192719Osom Ultra Plus Flu A&B Test KitSEKISUI Diagnostics, LLC2020-04-031900
K182001Acucy Influenza A&B Test with the Acucy SystemSEKISUI Diagnostics, LLC2018-12-171440
K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT MonSEKISUI Diagnostics, LLC2018-06-22210
K121397OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTRSEKISUI Diagnostics, LLC2012-12-282330
K123182OSOM INFLUENZA A&B TEST MODEL 190SEKISUI Diagnostics, LLC2012-11-05260

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