510(k) Report

FDA applicant

Qingdao Kingon Medical Science and Technology Co., Ltd.

Qingdao, CN6 decisions2020–20250 recalls

FDA records 6 decisions for Qingdao Kingon Medical Science and Technology Co., Ltd. (Qingdao, CN) from 2020 to 2025: 6 510(k) clearances. All are in product code CAW (Generator, Oxygen, Portable). Since 2016 its 510(k)s took a median of 223 days from receipt to decision, against 243 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Qingdao Kingon Medical Science and Technology Co.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Qingdao Kingon Medical Science and Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2020: 12022: 12023: 22025: 2
2020high 2 (2023) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Qingdao Kingon Medical Science and Technology Co., Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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