FDA applicant
Daesung Maref Co., Ltd.
FDA records 14 decisions for Daesung Maref Co., Ltd. (Gunpo-Si, KR) from 2011 to 2023: 14 510(k) clearances. Most are in product codes IRP (Massager, Powered Inflatable Tube) and JOW (Sleeve, Limb, Compressible). Since 2016 its 510(k)s took a median of 241 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 9 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 Daesung Maref Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Daesung Maref 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 “Daesung”
FDA records each applicant name separately; these may or may not be the same firm.