510(k) Report

FDA applicant

Fas Medical, Ltd.

Indian Hills, CO2 decisions2000–20010 recalls

FDA records 2 decisions for Fas Medical, Ltd. (Indian Hills, CO) from 2000 to 2001: 2 510(k) clearances. All are in product code LJS (Catheter, Intravascular, Therapeutic…). Its devices cite 4 predicates, 1 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 Fas Medical, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Fas Medical, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fas Medical, 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?

  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K993614Fas Endoluminal BrushFas Medical, Ltd. · 20002cite it
  • K012641Fas Endoluminal BrushFas Medical, Ltd. · 20011cites it

What has FDA decided for it lately?

  • K012641Fas Endoluminal BrushFas Medical, Ltd. · 2001
  • K993614Fas Endoluminal BrushFas Medical, Ltd. · 2000

All 2 as Fas Medical, Ltd. →