Cleared Traditional

K955535 - LOUISVILLE LABS OXYGEN HEAD TENT

K955535 is an FDA 510(k) clearance for LOUISVILLE LABS OXYGEN HEAD TENT, manufactured by Louisville Laboratories, Inc.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K955535 · Louisville Laboratories, Inc. · Anesthesiology device
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Jul 1996
Decision
209d
Days
Class 2
Risk

K955535 is an FDA 510(k) clearance for the LOUISVILLE LABS OXYGEN HEAD TENT. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Louisville Laboratories, Inc. (Louisville, US). The FDA issued a Cleared decision on July 1, 1996 after a review of 209 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 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. Standard predicate reliance. 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 Louisville Laboratories, Inc. devices

FDA 510(k) Submission Details - K955535

510(k) Number K955535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1995
Decision Date July 01, 1996
Days to Decision 209 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 140d · This submission: 209d
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

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