510(k) Report

FDA applicant

Shan Dong Wei Gao Group Medical Polymer Products

Shan Nan Er Rd., Shanghai, CN3 decisions2009–20092 recalls

FDA records 3 decisions for Shan Dong Wei Gao Group Medical Polymer Products (Shan Nan Er Rd., Shanghai, CN) in 2009: 3 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and BRZ (Set, Blood Transfusion). Its devices cite 3 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Shan Dong Wei Gao Group Medical Polymer Products’s devices, and how often a recall has named them.

FDA decisions per year

3in 2009

2009: 3
2009high 3 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2014

2012: 12014: 1
2009high 1 (2012) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Shan Dong Wei Gao Group Medical Polymer Products by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FPASet, Administration, Intravascular2decisions
  • BRZSet, Blood Transfusion1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K090012Disposable Infusion SetShan Dong Wei Gao Group Medical Polymer Products · 20091cites it

What has FDA decided for it lately?

  • K090459Disposable Tpe Infusion SetShan Dong Wei Gao Group Medical Polymer Products · 2009
  • K090012Disposable Infusion SetShan Dong Wei Gao Group Medical Polymer Products · 20092 recalls
  • K083349Blood Transfusion SetShan Dong Wei Gao Group Medical Polymer Products · 2009

All 3 as Shan Dong Wei Gao Group Medical Polymer Products →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K090012Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set…Oct 10, 2014Class II
  • K090012Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site…Aug 3, 2012Class II