510(k) Report

FDA applicant

Smt Swiss Microtechnology AG

Littleton, CO1 decision2003–20030 recalls

FDA records 1 decision for Smt Swiss Microtechnology AG (Littleton, CO) in 2003: 1 510(k) clearance. All are in product code HKY (Tonometer, Manual). 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 Smt Swiss Microtechnology AG’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Smt Swiss Microtechnology AG since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Smt Swiss Microtechnology AG 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?

  • HKYTonometer, Manual1decision

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.

  • K032967Pascal Dynamic Contour TonometerSmt Swiss Microtechnology AG · 20031cites it

What has FDA decided for it lately?

  • K032967Pascal Dynamic Contour TonometerSmt Swiss Microtechnology AG · 2003

The one decision as Smt Swiss Microtechnology AG →