510(k) Report

FDA applicant

Guangzhou Easycess Medical Co.,Ltd

Guangzhou, CN2 decisions2022–20230 recalls

FDA records 2 decisions for Guangzhou Easycess Medical Co.,Ltd (Guangzhou, CN) from 2022 to 2023: 2 510(k) clearances. Most are in product codes QJP (Catheter, Percutaneous, Neurovasculature) and JCX (Apparatus, Suction, Ward Use, Portable…). 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, cardiovascular panel, where it files most

How often FDA has decided Guangzhou Easycess Medical Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2022: 12023: 1
2022high 1 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Guangzhou Easycess Medical Co.,Ltd by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QJPCatheter, Percutaneous, Neurovasculature1decision
  • JCXApparatus, Suction, Ward Use, Portable, Ac-Powered1decision

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?

  • K233428Easycess Aspiration PumpGuangzhou Easycess Medical Co.,Ltd · 2023
  • K213065Distal Access CatheterGuangzhou Easycess Medical Co.,Ltd · 2022

All 2 as Guangzhou Easycess Medical Co.,Ltd →