510(k) Report

FDA applicant

Copioumed International, Inc.

Taipei City, TW2 decisions2023–20260 recalls

FDA records 2 decisions for Copioumed International, Inc. (Taipei City, TW) from 2023 to 2026: 2 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and FYC (Gown, Isolation, 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 Copioumed International, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 12026 (partial year): 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Copioumed International, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FYAGown, Surgical1decision
  • FYCGown, Isolation, 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?

  • K251860Copioumed AAMI 3 Surgical GownCopioumed International, Inc. · 2026
  • K230135Copioumed Chemotherapy Isolation GownCopioumed International, Inc. · 2023

All 2 as Copioumed International, Inc. →

Other applicant names beginning “Copioumed”

FDA records each applicant name separately; these may or may not be the same firm.

Copioumed Intl., Inc. 8