FDA applicant
Mediana Co., Ltd.
FDA records 10 decisions for Mediana Co., Ltd. (Wonju-Si, KR) from 2005 to 2020: 10 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and MHX (Monitor, Physiological, Patient (With…). Since 2016 its 510(k)s took a median of 322 days from receipt to decision, against 179 for FDA’s reviews in the same codes and years. Its devices cite 30 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Mediana Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Mediana 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