FDA applicant
Shenzhen Envisen Industry Co., Ltd.
FDA records 2 decisions for Shenzhen Envisen Industry Co., Ltd. (Shenzhen, CN) from 2011 to 2022: 2 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and DQA (Oximeter). Its devices cite 10 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Shenzhen Envisen Industry Co. Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shenzhen Envisen Industry 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 2011.
Planning a device like Shenzhen Envisen Industry 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