510(k) Report

FDA applicant

Suzhou Hengrui Hongyuan Medical Co., Ltd.

Suzhou, CN2 decisions2021–20220 recalls

FDA records 2 decisions for Suzhou Hengrui Hongyuan Medical Co., Ltd. (Suzhou, CN) from 2021 to 2022: 2 510(k) clearances. Most are in product codes KRD (Device, Vascular, For Promoting Embolization) and KRA (Catheter, Continuous Flush). 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2022

2021: 12022: 1
2021high 1 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Suzhou Hengrui Hongyuan Medical Co., Ltd. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Suzhou Hengrui Hongyuan Medical Co.…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • KRDDevice, Vascular, For Promoting Embolization1decision
  • KRACatheter, Continuous Flush1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K212719Micro Catheter and Guidewire SystemSuzhou Hengrui Hongyuan Medical Co., Ltd. · 2022
  • K210562HRSpheres Narrow-Size Embolic MicrospheresSuzhou Hengrui Hongyuan Medical Co., Ltd. · 2021

All 2 as Suzhou Hengrui Hongyuan Medical Co., Ltd. →