FDA applicant
Bionet Co., Ltd.
FDA records 14 decisions for Bionet Co., Ltd. (Seoul, KR) from 2001 to 2023: 14 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and LOS (Unnamed device). Since 2016 its 510(k)s took a median of 251 days from receipt to decision, against 236 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Bionet Company, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bionet Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bionet 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