Atlas FDA

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

OIU — Predicate Candidate Screening

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

215 daysmedian FDA review time
368 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K151378Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 CFujirebio Diagnostics,Inc.2015-11-241860
K112624ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ERoche Diagnostics2012-09-103680
K103676FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROLFujirebio Diagnostics,Inc.2011-07-192150
K093957ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CFujirebio Diagnostics,Inc.2010-03-18850
K072939HE4 EIA, MODEL: 404-10 USFujirebio Diagnostics,Inc.2008-06-092360

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