FDA applicant
Contec Medical System Co., Ltd.
FDA records 12 decisions for Contec Medical System Co., Ltd. (Zhong Shan, Shanghai, CN) from 2008 to 2019: 12 510(k) clearances. Most are in product codes DQA (Oximeter) and DPS (Electrocardiograph). Its devices cite 14 predicates, 1 of them its own earlier devices. 1 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 System Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Contec Medical System 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.