510(k) Report

FDA applicant

Optonol, Ltd.

Rockville, MD2 decisions2002–20030 recalls

FDA records 2 decisions for Optonol, Ltd. (Rockville, MD) from 2002 to 2003: 2 510(k) clearances. All are in product code KYF (Implant, Eye Valve). Its devices cite 5 predicates, 1 of them its own earlier devices. 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 Optonol, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Optonol, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Optonol, Ltd. 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?

  • KYFImplant, Eye Valve2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K012852EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS VersionsOptonol, Ltd. · 20022cite it

What has FDA decided for it lately?

  • K030350Express Mini Glaucoma ShuntOptonol, Ltd. · 2003
  • K012852EX-Press Minature Glaucoma Implant, Models R-20, R-30, R-50, STS VersionsOptonol, Ltd. · 2002

All 2 as Optonol, Ltd. →