510(k) Report

FDA applicant

Betec Medical Science Co., Ltd.

Flagstaff, AZ1 decision2003–20030 recalls

FDA records 1 decision for Betec Medical Science Co., Ltd. (Flagstaff, AZ) in 2003: 1 510(k) clearance. All are in product code MEG (Syringe, Antistick). 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, general hospital panel, where it files most

How often FDA has decided Betec Medical Science Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Betec Medical Science Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Betec Medical Science Co., Ltd.’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?

  • MEGSyringe, Antistick1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K031909Betec Retractable Safety Syringe (5ML)Betec Medical Science Co., Ltd. · 2003

The one decision as Betec Medical Science Co., Ltd. →