510(k) Report

FDA applicant

Andros Incorporated

Walker, MI1 decision1983–19830 recalls

FDA records 1 decision for Andros Incorporated (Walker, MI) in 1983: 1 510(k) clearance. 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 Andros Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Andros Incorporated since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Andros Incorporated by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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What has FDA decided for it lately?

  • K830253End Tidal CO2 Analyzer #411Andros Incorporated · 1983

The one decision as Andros Incorporated →

Other applicant names beginning “Andros”

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

Andros Analyzers, Inc. 5