Cleared Traditional

K011592 - OXYGEN TREATMENT HOOD (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011592 · Amron International Diving Supply, Inc. · Anesthesiology device
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Jun 2002
Decision
391d
Days
Class 2
Risk

K011592 is an FDA 510(k) clearance for the OXYGEN TREATMENT HOOD. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Amron International Diving Supply, Inc. (Escondido, US). The FDA issued a Cleared decision on June 19, 2002 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Amron International Diving Supply, Inc. devices

Submission Details

510(k) Number K011592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2001
Decision Date June 19, 2002
Days to Decision 391 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
252d slower than avg
Panel avg: 139d · This submission: 391d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.