Atlas FDA

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

Gen Trak, Inc. — Predicate Candidate Screening

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

235 daysmedian FDA review time
235 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K922084MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOMGen Trak, Inc.1992-07-28850
K922085MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOMGen Trak, Inc.1992-07-28850
K914847CD8 MONOCLONAL ANTIBODIESGen Trak, Inc.1992-06-192350
K914848CD4 MONOCLONAL ANTIBODIESGen Trak, Inc.1992-06-192350
K914846CD2 MONOCLONAL ANTIBODIESGen Trak, Inc.1992-06-192350

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