FDA applicant
Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.
FDA records 4 decisions for Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. (Shanghai, CN) from 2024 to 2026: 4 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). Since 2016 its 510(k)s took a median of 107 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 3 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 Fimilla (Shanghai) Maternity & Baby Articles 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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