510(k) Report

FDA applicant

Xiamen Probtain Medical Techology Co., Ltd.

Xiamen, CN4 decisions2020–20230 recalls

FDA records 4 decisions for Xiamen Probtain Medical Techology Co., Ltd. (Xiamen, CN) from 2020 to 2023: 4 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and FYA (Gown, Surgical). Since 2016 its 510(k)s took a median of 136 days from receipt to decision, against 138 for FDA’s reviews in the same codes and years. Its devices cite 4 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 Xiamen Probtain Medical Techology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2020: 12021: 12023: 2
2020high 2 (2023) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Xiamen Probtain Medical Techology Co., Ltd. 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, Surgical2decisions
  • FYAGown, Surgical1decision
  • FYCGown, Isolation, Surgical1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 136 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 138 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K223401Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd. · 2023
  • K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd. · 2023
  • K202954Disposable Surgical MaskXiamen Probtain Medical Techology Co., Ltd. · 2021
  • K201893Disposable Surgical MaskXiamen Probtain Medical Techology Co., Ltd. · 2020

All 4 as Xiamen Probtain Medical Techology Co., Ltd. →