510(k) Report

FDA applicant

Arisil Medical

Brooklyn, NY1 decision1995–19950 recalls

FDA records 1 decision for Arisil Medical (Brooklyn, NY) in 1995: 1 510(k) clearance. All are in product code MJV (Device, Inflation, Middle Ear). 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 Arisil Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Arisil Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Arisil Medical 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?

  • MJVDevice, Inflation, Middle Ear1decision

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.

  • K951596EarclearArisil Medical · 19951cites it

What has FDA decided for it lately?

  • K951596EarclearArisil Medical · 1995

The one decision as Arisil Medical →