510(k) Report

FDA applicant

Guangzhou Improve Medical Instruments Co., Ltd.

Shanghai, CN2 decisions2010–20160 recalls

FDA records 2 decisions for Guangzhou Improve Medical Instruments Co., Ltd. (Shanghai, CN) from 2010 to 2016: 2 510(k) clearances. Most are in product codes JKA (Tubes, Vials, Systems, Serum Separators, Blood…) and FMI (Needle, Hypodermic, Single Lumen). Its devices cite 4 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, clinical chemistry panel, where it files most

How often FDA has decided Guangzhou Improve Medical Instruments Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2010: 12016: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Guangzhou Improve Medical Instruments Co., Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JKATubes, Vials, Systems, Serum Separators, Blood Collection1decision
  • FMINeedle, Hypodermic, Single Lumen1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K153388IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached…Guangzhou Improve Medical Instruments Co., Ltd. · 2016
  • K093910Improvacuter Gel & Clot Activator TubeGuangzhou Improve Medical Instruments Co., Ltd. · 2010

All 2 as Guangzhou Improve Medical Instruments Co., Ltd. →