510(k) Report

FDA applicant

Yangzhou Medline Industry, Co., Ltd.

Yangzhou, CN2 decisions2017–20230 recalls

FDA records 2 decisions for Yangzhou Medline Industry, Co., Ltd. (Yangzhou, CN) from 2017 to 2023: 2 510(k) clearances. Most are in product codes JKA (Tubes, Vials, Systems, Serum Separators, Blood…) and MEG (Syringe, Antistick). Its devices cite 3 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, clinical chemistry panel, where it files most

How often FDA has decided Yangzhou Medline Industry, Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2017: 12023: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Yangzhou Medline Industry, Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Yangzhou Medline Industry, Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JKATubes, Vials, Systems, Serum Separators, Blood Collection1decision
  • MEGSyringe, Antistick1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 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.

  • K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 20176cite it
  • K230080Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection…Yangzhou Medline Industry, Co., Ltd. · 20231cites it

What has FDA decided for it lately?

  • K230080Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection…Yangzhou Medline Industry, Co., Ltd. · 2023
  • K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017

All 2 as Yangzhou Medline Industry, Co., Ltd. →