510(k) Report

FDA applicant

Youcare Technology Co.,Ltd. (Wuhan)

Wuhan, CN2 decisions2023–20230 recalls

FDA records 2 decisions for Youcare Technology Co.,Ltd. (Wuhan) (Wuhan, CN) in 2023: 2 510(k) clearances. Most are in product codes FED (Endoscopic Access Overtube…) and LJE (Catheter, Nephrostomy). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Youcare Technology Co.,Ltd. (Wuhan)’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2023: 2
2023high 2 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Youcare Technology Co.,Ltd. (Wuhan) by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FEDEndoscopic Access Overtube, Gastroenterology-Urology1decision
  • LJECatheter, Nephrostomy1decision

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 2 times; 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.

  • K230748Disposable Ureteral Access SheathYoucare Technology Co.,Ltd. (Wuhan) · 20232cite it

What has FDA decided for it lately?

  • K230748Disposable Ureteral Access SheathYoucare Technology Co.,Ltd. (Wuhan) · 2023
  • K222705Introducer NeedleYoucare Technology Co.,Ltd. (Wuhan) · 2023

All 2 as Youcare Technology Co.,Ltd. (Wuhan) →