510(k) Report

FDA applicant

Suzhou Hengrui Disheng Medical Co., Ltd.

Suzhou 215163, CN3 decisions2018–20200 recalls

FDA records 3 decisions for Suzhou Hengrui Disheng Medical Co., Ltd. (Suzhou 215163, CN) from 2018 to 2020: 3 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and KRA (Catheter, Continuous Flush). Since 2016 its 510(k)s took a median of 220 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. 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, cardiovascular panel, where it files most

How often FDA has decided Suzhou Hengrui Disheng Medical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2018: 12020: 2
2018high 2 (2020) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

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

Planning a device like Suzhou Hengrui Disheng Medical 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?

  • DQXWire, Guide, Catheter1decision
  • KRACatheter, Continuous Flush1decision
  • DQOCatheter, Intravascular, Diagnostic1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 220 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 106 days; 0 of its 3 were faster than that.

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 1 time; 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.

  • K171665Microcatheter and guide-wire systemSuzhou Hengrui Disheng Medical Co., Ltd. · 20181cites it

What has FDA decided for it lately?

  • K193653Hydrophilic Coating Guide WireSuzhou Hengrui Disheng Medical Co., Ltd. · 2020
  • K193647Superpipe Angiographic CatheterSuzhou Hengrui Disheng Medical Co., Ltd. · 2020
  • K171665Microcatheter and guide-wire systemSuzhou Hengrui Disheng Medical Co., Ltd. · 2018

All 3 as Suzhou Hengrui Disheng Medical Co., Ltd. →