510(k) Report

FDA applicant

Orbtek, Inc.

Salt Lake City, UT2 decisions1994–19970 recalls

FDA records 2 decisions for Orbtek, Inc. (Salt Lake City, UT) from 1994 to 1997: 2 510(k) clearances. Most are in product codes HLQ (Keratoscope, Ac-Powered) and MMQ (Topographer, Corneal, Ac-Powered). 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Orbtek, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Orbtek, Inc. 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?

  • HLQKeratoscope, Ac-Powered1decision
  • MMQTopographer, Corneal, Ac-Powered1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K940647Orbscan (TM) KeratometerOrbtek, Inc. · 19941cites it

What has FDA decided for it lately?

  • K964891Orbshot KeratometerOrbtek, Inc. · 1997
  • K940647Orbscan (TM) KeratometerOrbtek, Inc. · 1994

All 2 as Orbtek, Inc. →