510(k) Report

FDA applicant

Zhejiang Horizon Medical Technology Co., Ltd.

Jiaxing, CN2 decisions2023–20240 recalls

FDA records 2 decisions for Zhejiang Horizon Medical Technology Co., Ltd. (Jiaxing, CN) from 2023 to 2024: 2 510(k) clearances. Most are in product codes MQL (Media, Reproductive) and MQE (Needle, Assisted Reproduction). Its devices cite 2 predicates, 0 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 Zhejiang Horizon Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023: 12024: 1
2023high 1 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Zhejiang Horizon Medical Technology Co., Ltd. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zhejiang Horizon Medical Technology…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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