Atlas FDA

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

Zeus Scientific — Predicate Candidate Screening

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

218 daysmedian FDA review time
417 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K250814Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSZeus Scientific2026-05-084170
K250666Alegria Flash CTD ScreenZeus Scientific2025-10-222310
K250408Alegria Flash ENA ScreenZeus Scientific2025-09-192180
K243776Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); AntiZeus Scientific2025-05-071490
K231616ZEUS IFA(TM) nDNA Test System, ZEUS dIFineZeus Scientific2023-08-31900
K230863ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUSZeus Scientific2023-07-131060

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