FDA applicant
Bistos Co., Ltd.
FDA records 11 decisions for Bistos Co., Ltd. (Seongnam-Si, KR) from 2005 to 2025: 11 510(k) clearances. Most are in product codes HGM (System, Monitoring, Perinatal) and HGX (Pump, Breast, Powered). Since 2016 its 510(k)s took a median of 212 days from receipt to decision, against 122 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 4 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 Bistos Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bistos 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