510(k) Report

FDA applicant

Mcneill Intl., Inc.

Willoughby, OH1 decision1990–19900 recalls

FDA records 1 decision for Mcneill Intl., Inc. (Willoughby, OH) in 1990: 1 510(k) clearance. All are in product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase). 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, anesthesiology panel, where it files most

How often FDA has decided Mcneill Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mcneill Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mcneill Intl., Inc. 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?

  • CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase1decision

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.

  • K902113Vitalograph - Breathco MonitorMcneill Intl., Inc. · 19901cites it

What has FDA decided for it lately?

  • K902113Vitalograph - Breathco MonitorMcneill Intl., Inc. · 1990

The one decision as Mcneill Intl., Inc. →