FDA applicant
Zeus Scientific, Inc.
FDA records 145 decisions for Zeus Scientific, Inc. (Branchburg, NJ) from 1976 to 2026: 142 510(k) clearances and 3 original PMA approvals. Most are in product codes LSR (Reagent, Borrelia Serological Reagent) and MID (System, Test, Anticardiolipin Immunological). Since 2016 its 510(k)s took a median of 82 days from receipt to decision, against 86 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 5 of them its own earlier devices. 11 recalls are linked to its devices.
FDA’s records also spell it “Zeus Scientific”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Zeus Scientific, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
2in 2023
Class I Class II/III not classified
Planning a device like Zeus Scientific, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Zeus”
FDA records each applicant name separately; these may or may not be the same firm.