510(k) Report

FDA applicant

Jiangsu Newvalue Medical Producst Co.,Ltd

Taizhou, CN1 decision2018–20180 recalls

FDA records 1 decision for Jiangsu Newvalue Medical Producst Co.,Ltd (Taizhou, CN) in 2018: 1 510(k) clearance. All are in product code KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 1 predicate, 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

How often FDA has decided Jiangsu Newvalue Medical Producst Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Jiangsu Newvalue Medical Producst Co.,Ltd by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KGNWound Dressing With Animal-Derived Material (S)1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K173005SURECELL Gelling Fiber Wound DressingJiangsu Newvalue Medical Producst Co.,Ltd · 2018

The one decision as Jiangsu Newvalue Medical Producst Co.,Ltd →