510(k) Report

FDA applicant

Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.

Jiang Su, CN2 decisions2016–20160 recalls

FDA records 2 decisions for Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. (Jiang Su, CN) in 2016: 2 510(k) clearances. All are in product code DQA (Oximeter). 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, cardiovascular panel, where it files most

How often FDA has decided Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2016: 2
2016high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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