510(k) Report

FDA applicant

Occam Design

Louisville, KY1 decision2010–20100 recalls

FDA records 1 decision for Occam Design (Louisville, KY) in 2010: 1 510(k) clearance. All are in product code MLY (Vapocoolant Device). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Occam Design’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Occam Design by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MLYVapocoolant Device1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K093951Ouchless Model PN10114Occam Design · 20102cite it

What has FDA decided for it lately?

  • K093951Ouchless Model PN10114Occam Design · 2010

The one decision as Occam Design →