510(k) Report

FDA applicant

Wuxi Xinzhongrui Baby Supplies Co., Ltd.

Wuxi, CN3 decisions2015–20210 recalls

FDA records 3 decisions for Wuxi Xinzhongrui Baby Supplies Co., Ltd. (Wuxi, CN) from 2015 to 2021: 3 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). Its devices cite 3 predicates, 2 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, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Wuxi Xinzhongrui Baby Supplies Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2015: 22021: 1
2015high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Wuxi Xinzhongrui Baby Supplies Co., Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wuxi Xinzhongrui Baby Supplies 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

Other applicant names beginning “Wuxi”

FDA records each applicant name separately; these may or may not be the same firm.