510(k) Report

FDA applicant

Yue Pfong International Industrial Co., Ltd.

Flagstaff, AZ1 decision2004–20040 recalls

FDA records 1 decision for Yue Pfong International Industrial Co., Ltd. (Flagstaff, AZ) in 2004: 1 510(k) clearance. All are in product code MEG (Syringe, Antistick). Its devices cite 1 predicate, 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, general hospital panel, where it files most

How often FDA has decided Yue Pfong International Industrial Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Yue Pfong International Industrial Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MEGSyringe, Antistick1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K040105Yue Pfong Safety Syringe (3ML)Yue Pfong International Industrial Co., Ltd. · 2004

The one decision as Yue Pfong International Industrial Co., Ltd. →