FDA applicant
Contec Medical Systems Co.,Ltd
FDA records 12 decisions for Contec Medical Systems Co.,Ltd (Qinhuangdao, CN) from 2011 to 2024: 12 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and DXN (System, Measurement, Blood-Pressure…). Since 2016 its 510(k)s took a median of 227 days from receipt to decision, against 192 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 2 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 Contec Medical Systems Co.,Ltd’s devices, and how often a recall has named them.
FDA decisions per year
3in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Contec Medical Systems 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 “Contec”
FDA records each applicant name separately; these may or may not be the same firm.