FDA applicant
Ya Horng Electronic Co., Ltd.
FDA records 10 decisions for Ya Horng Electronic Co., Ltd. (Hsin-Chu City, TW) from 2004 to 2022: 10 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and DXQ (Blood Pressure Cuff). Its devices cite 9 predicates, 3 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 Ya Horng Electronic Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ya Horng Electronic 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