FDA applicant
Bay Labs, Inc.
FDA records 2 decisions for Bay Labs, Inc. (San Francisco, CA) from 2018 to 2020: 1 510(k) clearance and 1 De Novo grant. Most are in product codes QJU (Image Acquisition And/Or Optimization Guided…) and LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bay Labs, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Bay Labs, 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) Report