510(k) Report

FDA applicant

Unicoglobal, Inc.

Seongnam, KR2 decisions2021–20210 recalls

FDA records 2 decisions for Unicoglobal, Inc. (Seongnam, KR) in 2021: 2 510(k) clearances. Most are in product codes FYA (Gown, Surgical) and 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 Unicoglobal, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2021: 2
2021high 2 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Unicoglobal, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Unicoglobal, Inc.’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?

  • FYAGown, Surgical1decision
  • FXXMask, Surgical1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K210147Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face ShieldUnicoglobal, Inc. · 20211cites it

What has FDA decided for it lately?

  • K210147Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face ShieldUnicoglobal, Inc. · 2021
  • K203539Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE)Unicoglobal, Inc. · 2021

All 2 as Unicoglobal, Inc. →