510(k) Report

FDA applicant

Oculinum, Inc.

Berkeley, CA3 decisions1986–19900 recalls

FDA records 3 decisions for Oculinum, Inc. (Berkeley, CA) from 1986 to 1990: 3 510(k) clearances. All are in product code HLW (Preamplifier, Battery-Powered, Ophthalmic). 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 Oculinum, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oculinum, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Oculinum, 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?

  • HLWPreamplifier, Battery-Powered, Ophthalmic3decisions

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.

  • K900098Monopolar Needle ElectrodeOculinum, Inc. · 19901cites it

What has FDA decided for it lately?

  • K900279Oculinum Injection AmplifierOculinum, Inc. · 1990
  • K900098Monopolar Needle ElectrodeOculinum, Inc. · 1990
  • K854793Monopolar Injection Needle ElectrodeOculinum, Inc. · 1986

All 3 as Oculinum, Inc. →