FDA applicant
Shenzhen AOJ Medical Technology Co., Ltd.
FDA records 17 decisions for Shenzhen AOJ Medical Technology Co., Ltd. (Shenzhen, CN) from 2018 to 2026: 17 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and FLL (Continuous Measurement Thermometer). Since 2016 its 510(k)s took a median of 125 days from receipt to decision, against 154 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 8 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 Shenzhen AOJ Medical Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Shenzhen AOJ Medical Technology Co.…’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