510(k) Report

FDA applicant

Hydron, Ltd.

Farnborough, Hants, GB3 decisions1999–20060 recalls

FDA records 3 decisions for Hydron, Ltd. (Farnborough, Hants, GB) from 1999 to 2006: 3 510(k) clearances. Most are in product codes LPL (Lenses, Soft Contact, Daily Wear) and HPZ (Implant, Eye Sphere). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Hydron Pty Limited”.

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 Hydron, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hydron, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hydron, 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?

  • LPLLenses, Soft Contact, Daily Wear2decisions
  • HPZImplant, Eye Sphere1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 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.

  • K983637Actifresh 400 LensHydron, Ltd. · 19997cite it

What has FDA decided for it lately?

  • K053298Alphasphere Orbital ImplantHydron Pty Limited · 2006
  • K983637Actifresh 400 LensHydron, Ltd. · 1999
  • K983160Actitoric (Ocufilcon a) Soft (Hydrophilic) Toric Contact Lens for Daily WearHydron, Ltd. · 1999

All 2 as Hydron, Ltd. →The one decision as Hydron Pty Limited →