FDA applicant
AIOBIO Co., Ltd.
FDA records 2 decisions for AIOBIO Co., Ltd. (Seongnam-Si, KR) from 2019 to 2024: 2 510(k) clearances. Most are in product codes EIA (Unit, Operative Dental) and NBL (Light-Induced Fluorescence Caries Detector). Its devices cite 2 predicates, 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 AIOBIO Co., Ltd.’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 2019.
Planning a device like AIOBIO Co., Ltd.’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