510(k) Report

FDA applicant

Aok Tooling Limited

Shenzhen, CN3 decisions2020–20220 recalls

FDA records 3 decisions for Aok Tooling Limited (Shenzhen, CN) from 2020 to 2022: 3 510(k) clearances. All are in product code FXX (Mask, Surgical). Since 2016 its 510(k)s took a median of 124 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 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 Aok Tooling Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2020: 12021: 12022: 1
2020high 1 (2020) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Aok Tooling Limited by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FXXMask, Surgical3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 124 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 113 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K211956039 Surgical Face MaskAok Tooling Limited · 20211cites it

What has FDA decided for it lately?

  • K220876AOK 95A Medical Mask (20200049)Aok Tooling Limited · 2022
  • K211956039 Surgical Face MaskAok Tooling Limited · 2021
  • K201517Plain Surgical MaskAok Tooling Limited · 2020

All 3 as Aok Tooling Limited →