Cleared Traditional

K955482 - SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) (FDA 510(k) Clearance)

Class I Anesthesiology device.

K955482 · Advantage Medical Services, Inc. · Anesthesiology device
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Jan 1996
Decision
90d
Days
Class 1
Risk

K955482 is an FDA 510(k) clearance for the SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION). Classified as Hood, Oxygen, Infant (product code FOG), Class I - General Controls.

Submitted by Advantage Medical Services, Inc. (Edgerton, US). The FDA issued a Cleared decision on January 30, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5700 - 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 Advantage Medical Services, Inc. devices

Submission Details

510(k) Number K955482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1995
Decision Date January 30, 1996
Days to Decision 90 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
49d faster than avg
Panel avg: 139d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FOG Hood, Oxygen, Infant
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.