FDA applicant
Solco Biomedical Co., Ltd.
FDA records 17 decisions for Solco Biomedical Co., Ltd. (Rockville, MD) from 2005 to 2024: 17 510(k) clearances. Most are in product codes MNH (Orthosis, Spondylolisthesis Spinal Fixation) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 174 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 41 predicates, 8 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 Solco Biomedical Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Solco Biomedical 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 “Solco”
FDA records each applicant name separately; these may or may not be the same firm.