510(k) Report

FDA applicant

Life-Shield Products, Inc.

Taipei, TW5 decisions2003–20070 recalls

FDA records 5 decisions for Life-Shield Products, Inc. (Taipei, TW) from 2003 to 2007: 5 510(k) clearances. All are in product code MEG (Syringe, Antistick). Its devices cite 10 predicates, 4 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 Life-Shield Products, Inc.’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 — Life-Shield Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Life-Shield Products, Inc.’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, Antistick5decisions

Whose devices does it build on?

Its devices cite 10 predicates; 4 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K030976Careo Retractable Safety SyringeLife-Shield Products, Inc. · 20031cites it
  • K061055Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc. · 20061cites it
  • K052397Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML)Life-Shield Products, Inc. · 20051cites it
  • K060208Careo Safety Syringe 1CC/ML, Models…Life-Shield Products, Inc. · 20061cites it

What has FDA decided for it lately?

  • K072037Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc. · 2007
  • K061055Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc. · 2006
  • K060208Careo Safety Syringe 1CC/ML, Models…Life-Shield Products, Inc. · 2006
  • K052397Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML)Life-Shield Products, Inc. · 2005
  • K030976Careo Retractable Safety SyringeLife-Shield Products, Inc. · 2003

All 5 as Life-Shield Products, Inc. →