FDA applicant
Limbus Ai, Inc.
FDA records 3 decisions for Limbus Ai, Inc. (Regina, CA) from 2020 to 2024: 3 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QKB (Radiological Image Processing Software For…). Since 2016 its 510(k)s took a median of 98 days from receipt to decision, against 157 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 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 Limbus Ai, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Limbus Ai, 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