Atlas FDA

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

GSO — Predicate Candidate Screening

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

70 daysmedian FDA review time
71 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K972394VISTA ANTIGEN BRUCELLA ABORTUSLee Laboratories, Inc.1997-08-25600
K972396VISTA ANTIGEN BRUCELLA MELITENSISLee Laboratories, Inc.1997-08-25600
K952139SAS BRUCELLA SUIS ANTIGENSa Scientific, Inc.1995-07-18710
K952137SAS SALMONELLA H A ANTIGENSa Scientific, Inc.1995-07-17700
K952131SAS FEBRILE ANTIGEN SETSa Scientific, Inc.1995-07-17700
K952140SAS BRUCELLA MELTIENSIS ANTIGENSa Scientific, Inc.1995-07-17700
K952147SAS BRUCELLA ABORTUS ANTIGENSa Scientific, Inc.1995-07-17700
K952136SAS SALMONELLA H B ANTIGENSa Scientific, Inc.1995-07-17700
K952135SAS SALMONELLA H D ANTIGENSa Scientific, Inc.1995-07-17700
K885112BRUCELLA IFA*Investigacion Farmaceutica S.A. DE C.V.1989-08-152460
K822663FEBRILE ANTIGEN KITOxoid U.S.A., Inc.1982-09-21180
K791449AGGLUTINOTEST-BRUCELLAVolu Sol Medical Industries1979-09-24490

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