FDA applicant
Shenzhen Root Innovation Technology Co., Ltd.
FDA records 13 decisions for Shenzhen Root Innovation Technology Co., Ltd. (Shenzhen, CN) from 2024 to 2026: 13 510(k) clearances. Most are in product codes HGX (Pump, Breast, Powered) and BTA (Pump, Portable, Aspiration (Manual Or Powered)). Since 2016 its 510(k)s took a median of 119 days from receipt to decision, against 142 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Shenzhen Root Innovation Technology Co., , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Shenzhen Root Innovation Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
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