510(k) Report

FDA applicant

Kenpax International Limited

Hong Kong, CN4 decisions2021–20230 recalls

FDA records 4 decisions for Kenpax International Limited (Hong Kong, CN) from 2021 to 2023: 4 510(k) clearances. Most are in product codes FYC (Gown, Isolation, Surgical) and FRG (Wrap, Sterilization). Since 2016 its 510(k)s took a median of 233 days from receipt to decision, against 182 for FDA’s reviews in the same codes and years. 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 Kenpax International Limited’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2021: 22023: 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 — Kenpax International Limited by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FYCGown, Isolation, Surgical1decision
  • FRGWrap, Sterilization1decision
  • QPCGown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection1decision
  • FXXMask, Surgical1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 233 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 182 days; 1 of its 3 were faster than that.

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.

  • K202899Procedure Mask, Surgical MaskKenpax International Limited · 20211cites it

What has FDA decided for it lately?

  • K222128Protective Gown AAMI Level 4Kenpax International Limited · 2023
  • K222151Sterilization WrapKenpax International Limited · 2023
  • K212504Isolation Gown AAMI Level 3Kenpax International Limited · 2021
  • K202899Procedure Mask, Surgical MaskKenpax International Limited · 2021

All 4 as Kenpax International Limited →