510(k) Report

FDA applicant

Reneau, Inc.

Walker, MI1 decision1984–19840 recalls

FDA records 1 decision for Reneau, Inc. (Walker, MI) in 1984: 1 510(k) clearance. All are in product code CBF (Chamber, Hyperbaric). 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 Reneau, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Reneau, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Reneau, 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?

  • CBFChamber, Hyperbaric1decision

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.

  • K840841Reneau UnitReneau, Inc. · 19841cites it

What has FDA decided for it lately?

  • K840841Reneau UnitReneau, Inc. · 1984

The one decision as Reneau, Inc. →