510(k) Report

FDA applicant

Airel-West

Washington, DC1 decision1997–19970 recalls

FDA records 1 decision for Airel-West (Washington, DC) in 1997: 1 510(k) clearance. All are in product code EIA (Unit, Operative Dental). 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, dental panel, where it files most

How often FDA has decided Airel-West’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Airel-West since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Airel-West 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?

  • EIAUnit, Operative Dental1decision

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.

  • K964271Ign 500 TM Water Cleaning Unit with Calbenium LiquidAirel-West · 19971cites it

What has FDA decided for it lately?

  • K964271Ign 500 TM Water Cleaning Unit with Calbenium LiquidAirel-West · 1997

The one decision as Airel-West →