510(k) Report

FDA applicant

Suzhou Sniper Medical Technologies Co., Ltd.

Suzhou, CN1 decision2023–20230 recalls

FDA records 1 decision for Suzhou Sniper Medical Technologies Co., Ltd. (Suzhou, CN) in 2023: 1 510(k) clearance. All are in product code OYX (Bcr/Abl1 Monitoring Test). Its devices cite 1 predicate, 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

How often FDA has decided Suzhou Sniper Medical Technologies Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

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

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