510(k) Report

FDA applicant

Bay Area Hypersciences, LLC

Houston, TX1 decision2003–20030 recalls

FDA records 1 decision for Bay Area Hypersciences, LLC (Houston, TX) in 2003: 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 Bay Area Hypersciences, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bay Area Hypersciences, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bay Area Hypersciences, LLC 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

What has FDA decided for it lately?

  • K030713Bay Area HypersciencesBay Area Hypersciences, LLC · 2003

The one decision as Bay Area Hypersciences, LLC →