510(k) Report

FDA applicant

Mortan, Inc.

Missoula, MT2 decisions1983–19870 recalls

FDA records 2 decisions for Mortan, Inc. (Missoula, MT) from 1983 to 1987: 2 510(k) clearances. All are in product code KYG (Device, Irrigation, Ocular Surgery). 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 Mortan, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mortan, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mortan, 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?

  • KYGDevice, Irrigation, Ocular Surgery2decisions

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.

  • K821897LENSMortan, Inc. · 19831cites it

What has FDA decided for it lately?

  • K871454Morgan Therapeutic LensMortan, Inc. · 1987
  • K821897LENSMortan, Inc. · 1983

All 2 as Mortan, Inc. →