Cleared Abbreviated

K030713 - BAY AREA HYPERSCIENCES

K030713 is an FDA 510(k) clearance for BAY AREA HYPERSCIENCES, manufactured by Bay Area Hypersciences, LLC. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Abbreviated 510(k) pathway after a 288-day FDA review.

K030713 · Bay Area Hypersciences, LLC · Anesthesiology device
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Dec 2003
Decision
288d
Days
Class 2
Risk

K030713 is an FDA 510(k) clearance for the BAY AREA HYPERSCIENCES. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Bay Area Hypersciences, LLC (Houston, US). The FDA issued a Cleared decision on December 19, 2003 after a review of 288 days - an extended review 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.

FDA 510(k) Submission Details - K030713

510(k) Number K030713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2003
Decision Date December 19, 2003
Days to Decision 288 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 140d · This submission: 288d
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 67
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K030713.
ATA HCM MONOPLACE HYPERBARIC SYSTEM
K040145 · Ata Hyperbaric Chamber Manufacturing · May 2005
MILLENIUM, MODELS 2000, 2001 AND 2002
K041007 · Hyperbaric For Life, LLC · Nov 2004
MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM
K030418 · Makai Marine Industries, Inc. · Jan 2004
SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES
K031649 · Fink Engineering Pty, Ltd. · Dec 2003
MSI I2010 DUAL PLACE HYPERBARIC CHAMBER
K022214 · Mechidyne Systems, Inc. · Feb 2003
PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2
K021689 · Pan-America Hyperbarics, Inc. · Oct 2002
K030713 · BAY AREA HYPERSCIENCES
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