510(k) Report

FDA applicant

Rose K International, Ltd.

Hamilton, NZ2 decisions1995–20020 recalls

FDA records 2 decisions for Rose K International, Ltd. (Hamilton, NZ) from 1995 to 2002: 2 510(k) clearances. All are in product code HQD (Lens, Contact (Other Material) - Daily). 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 Rose K International, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rose K International, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rose K International, 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?

  • HQDLens, Contact (Other Material) - Daily2decisions

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.

  • K013646Rose K Post Graft LensRose K International, Ltd. · 20022cite it
  • K945955Rose K LensRose K International, Ltd. · 19951cites it

What has FDA decided for it lately?

  • K013646Rose K Post Graft LensRose K International, Ltd. · 2002
  • K945955Rose K LensRose K International, Ltd. · 1995

All 2 as Rose K International, Ltd. →

Other applicant names beginning “Rose”

FDA records each applicant name separately; these may or may not be the same firm.

Rose KG 1