510(k) Report

FDA applicant

Doran Instruments, Inc.

Littleton, MA2 decisions1986–19920 recalls

FDA records 2 decisions for Doran Instruments, Inc. (Littleton, MA) from 1986 to 1992: 2 510(k) clearances. Most are in product codes HLZ (Electrode, Corneal) and GWE (Stimulator, Photic, Evoked Response). 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 Doran Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Doran Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Doran Instruments, 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?

  • HLZElectrode, Corneal1decision
  • GWEStimulator, Photic, Evoked Response1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K863956Maculoscope (TM)Doran Instruments, Inc. · 19863cite it

What has FDA decided for it lately?

  • K913239Goldlens (TM)Doran Instruments, Inc. · 1992
  • K863956Maculoscope (TM)Doran Instruments, Inc. · 1986

All 2 as Doran Instruments, Inc. →