510(k) Report

FDA applicant

All Medicus Co., Ltd.

Anyang, Gyeonggi-Do, KR5 decisions2005–20170 recalls

FDA records 5 decisions for All Medicus Co., Ltd. (Anyang, Gyeonggi-Do, KR) from 2005 to 2017: 5 510(k) clearances. All are in product code NBW (System, Test, Blood Glucose, Over The Counter). Its devices cite 5 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

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided All Medicus Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2009: 22013: 12017: 1
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — All Medicus Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like All Medicus Co., Ltd.’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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