Atlas FDA

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

Sekisui Diagnostics P.E.I., Inc. — Predicate Candidate Screening

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

283 daysmedian FDA review time
525 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K202644AcetaminophenSekisui Diagnostics P.E.I., Inc.2022-02-185250
K182702SEKURE Creatine Kinase AssaySekisui Diagnostics P.E.I., Inc.2019-04-172020
K180835SEKURE Acetaminophen L3K AssaySekisui Diagnostics P.E.I., Inc.2019-02-083150
K173206SEKURE HbA1c AssaySekisui Diagnostics P.E.I., Inc.2018-07-122830
K163078DC-UIBC-CALSekisui Diagnostics P.E.I., Inc.2016-12-08350
K111915MAGNESIUM ASSAYSekisui Diagnostics P.E.I., Inc.2011-12-021490

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