510(k) Report

FDA applicant

Ikonos Corp.

Portland, OR3 decisions1997–19980 recalls

FDA records 3 decisions for Ikonos Corp. (Portland, OR) from 1997 to 1998: 3 510(k) clearances. Most are in product codes GXN (Plate, Cranioplasty, Preformed, Non-Alterable) and ETD (Tube, Tympanostomy). 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, neurology panel, where it files most

How often FDA has decided Ikonos Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ikonos Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ikonos Corp. 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?

  • GXNPlate, Cranioplasty, Preformed, Non-Alterable2decisions
  • ETDTube, Tympanostomy1decision

Who builds on its devices?

Later devices cite its devices 5 times; 0 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.

  • K971252Sevrain Cranial ClampIkonos Corp. · 19983cite it
  • K971408Sevrain Cranial Clamp (SCC-200 Series)Ikonos Corp. · 19982cite it

What has FDA decided for it lately?

  • K971252Sevrain Cranial ClampIkonos Corp. · 1998
  • K971408Sevrain Cranial Clamp (SCC-200 Series)Ikonos Corp. · 1998
  • K971454Tympanostomy Ventilation TubeIkonos Corp. · 1997

All 3 as Ikonos Corp. →