FDA applicant
Samsung Electronics Co., Ltd.
FDA records 43 decisions for Samsung Electronics Co., Ltd. (Suwon-Si, KR) from 2013 to 2026: 42 510(k) clearances and 1 De Novo grant. Most are in product codes KPR (System, X-Ray, Stationary) and IZL (System, X-Ray, Mobile). Since 2016 its 510(k)s took a median of 56 days from receipt to decision, against 75 for FDA’s reviews in the same codes and years. Its devices cite 70 predicates, 50 of them its own earlier devices. 7 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Samsung Electronics Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2024
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Samsung Electronics 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) ReportOther applicant names beginning “Samsung”
FDA records each applicant name separately; these may or may not be the same firm.