FDA applicant
U&I Corporation
FDA records 35 decisions for U&I Corporation (Uijeongbu-Si, KR) from 2005 to 2022: 35 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and MNH (Orthosis, Spondylolisthesis Spinal Fixation). Since 2016 its 510(k)s took a median of 41 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 113 predicates, 29 of them its own earlier devices. 2 recalls are linked to its devices.
FDA’s records also spell it “U&I Corp.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided U&I Corporation’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like U&I Corporation’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