Cleared Abbreviated

K081506 - HYPERBARIC AMERICA

K081506 is an FDA 510(k) clearance for HYPERBARIC AMERICA, manufactured by Hyperbaric America, LLC. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Abbreviated 510(k) pathway after a 57-day FDA review.

K081506 · Hyperbaric America, LLC · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
57d
Days
Class 2
Risk

K081506 is an FDA 510(k) clearance for the HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Hyperbaric America, LLC (San Antonio, US). The FDA issued a Cleared decision on July 25, 2008 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5470 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Hyperbaric America, LLC devices

FDA 510(k) Submission Details - K081506

510(k) Number K081506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2008
Decision Date July 25, 2008
Days to Decision 57 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 140d · This submission: 57d
Pathway characteristics
Standards-based clearance path.

CBF Device Classification - Class 2, Special Controls

Product Code CBF Chamber, Hyperbaric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5470
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBF Chamber, Hyperbaric

All 10
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K081506.
Revitalair 430F
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