FDA applicant
VATECH Co., Ltd.
FDA records 40 decisions for VATECH Co., Ltd. (Hwaseong-Si, KR) from 2008 to 2026: 40 510(k) clearances. Most are in product codes OAS (X-Ray, Tomography, Computed, Dental) and MUH (System, X-Ray, Extraoral Source, Digital). Since 2016 its 510(k)s took a median of 63 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 41 predicates, 26 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 VATECH Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like VATECH 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 “VATECH”
FDA records each applicant name separately; these may or may not be the same firm.