510(k) Report

FDA applicant

Sunder Biomedical Tech. Co., Ltd.

Taichung City, TW3 decisions2001–20030 recalls

FDA records 3 decisions for Sunder Biomedical Tech. Co., Ltd. (Taichung City, TW) from 2001 to 2003: 3 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and FIE (Needle, Fistula). 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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Sunder Biomedical Tech. Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sunder Biomedical Tech. Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sunder Biomedical Tech. Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision
  • FIENeedle, Fistula1decision
  • FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K024007Sunder Central Venous Catheter Kit, Models SD-3L55F30J and SD-3L70F30JSunder Biomedical Tech. Co., Ltd. · 20031cites it

What has FDA decided for it lately?

  • K024007Sunder Central Venous Catheter Kit, Models SD-3L55F30J and SD-3L70F30JSunder Biomedical Tech. Co., Ltd. · 2003
  • K014140Renax Hemodialysis Blood Tubing Set; Sunder Hemodialysis Blood Tubing SetSunder Biomedical Tech. Co., Ltd. · 2002
  • K003123Renax a.V. Fistula Needle SetsSunder Biomedical Tech. Co., Ltd. · 2001

All 3 as Sunder Biomedical Tech. Co., Ltd. →