510(k) Report

FDA applicant

Shuenn Bao Shing Corporation

Hsin Chu City, TW2 decisions1999–20080 recalls

FDA records 2 decisions for Shuenn Bao Shing Corporation (Hsin Chu City, TW) from 1999 to 2008: 2 510(k) clearances. Most are in product codes MSH (Respirator, Surgical) and FXX (Mask, Surgical). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Shuenn Bao Shing Corp.”.

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

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Shuenn Bao Shing Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shuenn Bao Shing Corporation 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?

  • MSHRespirator, Surgical1decision
  • FXXMask, Surgical1decision

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?

  • K072067N95 Surgical Respirator, Type AP0018 and AP0028Shuenn Bao Shing Corporation · 2008
  • K990719Earloop Face MaskShuenn Bao Shing Corp. · 1999

The one decision as Shuenn Bao Shing Corporation →The one decision as Shuenn Bao Shing Corp. →