510(k) Report

FDA applicant

Hangzhou Zeo-Innov Life Technology Co., Ltd.

Hangzhou, CN2 decisions2022–20230 recalls

FDA records 2 decisions for Hangzhou Zeo-Innov Life Technology Co., Ltd. (Hangzhou, CN) from 2022 to 2023: 2 510(k) clearances. All are in product code QSY (Hemostatic Wound Dressing Without Thrombin Or…). Its devices cite 2 predicates, 1 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

How often FDA has decided Hangzhou Zeo-Innov Life Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2022: 12023: 1
2022high 1 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Hangzhou Zeo-Innov Life Technology Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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