Cleared Traditional

K011565 - INFANT OXYGEN TREATMENT HOOD

K011565 is an FDA 510(k) clearance for INFANT OXYGEN TREATMENT HOOD, manufactured by Gulf Coast Hyperbarics, Inc.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K011565 · Gulf Coast Hyperbarics, Inc. · Anesthesiology device
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Aug 2001
Decision
87d
Days
Class 2
Risk

K011565 is an FDA 510(k) clearance for the INFANT OXYGEN TREATMENT HOOD. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Gulf Coast Hyperbarics, Inc. (Panama City, US). The FDA issued a Cleared decision on August 16, 2001 after a review of 87 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K011565

510(k) Number K011565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2001
Decision Date August 16, 2001
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 140d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 56
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K011565.
OXYGEN TREATMENT HOOD
K011592 · Amron International Diving Supply, Inc. · Jun 2002
OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES
K011866 · Hyperbaric Technologies, Inc. · Jun 2002
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
K001121 · Engineered Medical Technology, Inc. · Nov 2001
BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM
K011312 · Khrunichev State Research & Production Space Centr · Jul 2001
SEA-LONG MEDICAL TREATMENT HOOD
K010659 · Sea-Long Medical Systems, Inc. · May 2001
MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
K002794 · Hypertec, Inc. · Dec 2000