FDA applicant
Jmt Co., Ltd.
FDA records 4 decisions for Jmt Co., Ltd. (Yangju-Si, KR) from 2021 to 2025: 4 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and BSO (Catheter, Conduction, Anesthetic). Since 2016 its 510(k)s took a median of 440 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 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 Jmt 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 2021.
Planning a device like Jmt 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