510(k) Report

FDA applicant

Makai Marine Industries, Inc.

Boca Raton, FL1 decision2004–20040 recalls

FDA records 1 decision for Makai Marine Industries, Inc. (Boca Raton, FL) in 2004: 1 510(k) clearance. All are in product code CBF (Chamber, Hyperbaric). Its devices cite 4 predicates, 0 of them its own earlier devices. 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 Makai Marine Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Makai Marine Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Makai Marine Industries, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CBFChamber, Hyperbaric1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K030418Multiplace Hyperbaric System, Model Mmi Hyperbaric Chamber SystemMakai Marine Industries, Inc. · 2004

The one decision as Makai Marine Industries, Inc. →