Atlas FDA

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

GOE · Predicate Candidate Screening

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

616 daysmedian FDA review time
617 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K940026POLIOVIRUS BLEND MONOCLONAL ANTIBODIESLight Diagnostics1995-09-126170
K940027ENTEROVIRUS BLEND MONOCLONAL ANTIBODIESChemicon Intl., Inc.1995-09-126170
K940473ENTEROVIRUS 71 MONOCLONAL ANTIBODYChemicon Intl., Inc.1995-09-125870
K940034POLIOVIRUS 2 MONOCLONAL ANTIBODYLight Diagnostics1995-09-126160
K940017POLIOVIRUS 3 MONOCLONAL ANTIBODYLight Diagnostics1995-09-126160
K940018POLIOVIRUS 1 MONOCLONAL ANTIBODYLight Diagnostics1995-09-086120
K940363ENTEROVIRUS 70 MONCLONAL ANTIBODYLight Diagnostics1995-09-085900

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