510(k) Report

FDA applicant

Taiject Medical Device Co., Ltd.

Newport Beach, CA4 decisions2002–20040 recalls

FDA records 4 decisions for Taiject Medical Device Co., Ltd. (Newport Beach, CA) from 2002 to 2004: 4 510(k) clearances. All are in product code MEG (Syringe, Antistick). Its devices cite 5 predicates, 5 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 Taiject Medical Device Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Taiject Medical Device Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Taiject Medical Device 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?

  • MEGSyringe, Antistick4decisions

Who builds on its devices?

Later devices cite its devices 7 times; 5 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.

  • K022278TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML)Taiject Medical Device Co., Ltd. · 20025cite it
  • K031062TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100 Insulin/FA71 Series Tuberculin)Taiject Medical Device Co., Ltd. · 20031cites it
  • K023458TMD Safety Syringe (FA14 Series 10ML/FA15 Series 20ML)Taiject Medical Device Co., Ltd. · 20021cites it

What has FDA decided for it lately?

  • K042426TMD 0.5ML Safety Syringe (FA18 Series 0.5ML/FA58 Series U-100 Insulin/FA78 Series Tuberculin)Taiject Medical Device Co., Ltd. · 2004
  • K031062TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100 Insulin/FA71 Series Tuberculin)Taiject Medical Device Co., Ltd. · 2003
  • K023458TMD Safety Syringe (FA14 Series 10ML/FA15 Series 20ML)Taiject Medical Device Co., Ltd. · 2002
  • K022278TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML)Taiject Medical Device Co., Ltd. · 2002

All 4 as Taiject Medical Device Co., Ltd. →