510(k) Report

FDA applicant

Anhui Kangda Medical Products Co., Ltd.

Pudong, Shanghai, CN2 decisions2009–20091 recall

FDA records 2 decisions for Anhui Kangda Medical Products Co., Ltd. (Pudong, Shanghai, CN) in 2009: 2 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FMF (Syringe, Piston). 1 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, general hospital panel, where it files most

How often FDA has decided Anhui Kangda Medical Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2009: 2
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2009high 1 (2016) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Anhui Kangda Medical Products Co., Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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See the 510(k) Report

Which product codes does it file in?

  • FPASet, Administration, Intravascular1decision
  • FMFSyringe, Piston1decision

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.

  • K083687Baixin Intravascular Administration SetAnhui Kangda Medical Products Co., Ltd. · 20091cites it

What has FDA decided for it lately?

  • K083686Baixin Disposable Syringe, Multiple SizesAnhui Kangda Medical Products Co., Ltd. · 2009
  • K083687Baixin Intravascular Administration SetAnhui Kangda Medical Products Co., Ltd. · 20091 recall

All 2 as Anhui Kangda Medical Products Co., Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K083687ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall…Jan 6, 2016Class II