510(k) Report

FDA applicant

Suzhou Zenith Vascular SciTech Limited

Suzhou, CN4 decisions2025–20260 recalls

FDA records 4 decisions for Suzhou Zenith Vascular SciTech Limited (Suzhou, CN) from 2025 to 2026: 4 510(k) clearances. Most are in product codes MOF (Guide, Wire, Catheter, Neurovasculature) and KRA (Catheter, Continuous Flush). Since 2016 its 510(k)s took a median of 265 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 7 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 Suzhou Zenith Vascular SciTech Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 12026 (partial year): 3
2025high 3 (2026) · low 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Suzhou Zenith Vascular SciTech Limited by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MOFGuide, Wire, Catheter, Neurovasculature1decision
  • KRACatheter, Continuous Flush1decision
  • NRYCatheter, Thrombus Retriever1decision
  • QJPCatheter, Percutaneous, Neurovasculature1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 265 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 147 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited · 2026
  • K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited · 2026
  • K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited · 2026
  • K243534Micro CatheterSuzhou Zenith Vascular SciTech Limited · 2025

All 4 as Suzhou Zenith Vascular SciTech Limited →