510(k) Report

FDA applicant

Shandong Qiaopai Group Co., Ltd.

Zibo, CN1 decision2008–20080 recalls

FDA records 1 decision for Shandong Qiaopai Group Co., Ltd. (Zibo, CN) in 2008: 1 510(k) clearance. All are in product code FMI (Needle, Hypodermic, Single Lumen). 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, general hospital panel, where it files most

How often FDA has decided Shandong Qiaopai Group Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Shandong Qiaopai Group Co., Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMINeedle, Hypodermic, Single Lumen1decision

What has FDA decided for it lately?

  • K073705Model TW SB, Scalp Vein Set; Model TW LB, Sterile Hypodermic NeedleShandong Qiaopai Group Co., Ltd. · 2008

The one decision as Shandong Qiaopai Group Co., Ltd. →