510(k) Report

FDA applicant

Kostec Co., Ltd.

Hampton, VA2 decisions2013–20140 recalls

FDA records 2 decisions for Kostec Co., Ltd. (Hampton, VA) from 2013 to 2014: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and PGY (Display, Diagnostic Radiology). Its devices cite 2 predicates, 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, radiology panel, where it files most

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

FDA decisions per year

1in 2014

2013: 12014: 1
2013high 1 (2013) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Kostec Co., Ltd. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kostec 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?

  • LLZSystem, Image Processing, Radiological1decision
  • PGYDisplay, Diagnostic Radiology1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K141891Medical LCD MonitorKostec Co., Ltd. · 2014
  • K123944Kostec Medical Grade LDC MonitorsKostec Co., Ltd. · 2013

All 2 as Kostec Co., Ltd. →