510(k) Report

FDA applicant

China Surgical Dressings Center Co., Ltd.

Taipei, Taiwan, TW1 decision2005–20050 recalls

FDA records 1 decision for China Surgical Dressings Center Co., Ltd. (Taipei, Taiwan, TW) in 2005: 1 510(k) clearance. All are in product code FXX (Mask, Surgical). Its devices cite 2 predicates, 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 and plastic surgery panel, where it files most

How often FDA has decided China Surgical Dressings Center Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for China Surgical Dressings Center Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — China Surgical Dressings Center Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like China Surgical Dressings Center Co.…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FXXMask, Surgical1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K050689Surgical Face MaskChina Surgical Dressings Center Co., Ltd. · 2005

The one decision as China Surgical Dressings Center Co., Ltd. →