510(k) Report

FDA applicant

Biotop Technology Co., Ltd.

Hsin Chu City, TW4 decisions2004–20070 recalls

FDA records 4 decisions for Biotop Technology Co., Ltd. (Hsin Chu City, TW) from 2004 to 2007: 4 510(k) clearances. All are in product code MEG (Syringe, Antistick). Its devices cite 5 predicates, 3 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, general hospital panel, where it files most

How often FDA has decided Biotop Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biotop Technology 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?

  • MEGSyringe, Antistick4decisions

Whose devices does it build on?

Its devices cite 5 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K041970Biotop Hooksafe Safety Syringe, Models 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML and 10CC/MLBiotop Technology Co., Ltd. · 20042cite it
  • K032747Biotop DJT-a Safety SyringeBiotop Technology Co., Ltd. · 20042cite it

What has FDA decided for it lately?

  • K062318Biotop Hooksafe U-100 Insulin Syringe, Models 0.5CC/ML and 1CC/MLBiotop Technology Co., Ltd. · 2007
  • K043038Biotop Hooksafe Luer-Lock Safety Syringe, Models 3CC/ML, 5CC/ML and 10CC/MLBiotop Technology Co., Ltd. · 2004
  • K041970Biotop Hooksafe Safety Syringe, Models 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML and 10CC/MLBiotop Technology Co., Ltd. · 2004
  • K032747Biotop DJT-a Safety SyringeBiotop Technology Co., Ltd. · 2004

All 4 as Biotop Technology Co., Ltd. →