Cleared Traditional

K955482 - SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION)

K955482 is an FDA 510(k) clearance for SWIFT INFANT OXYGEN HOOD-REUSABLE (MODI..., manufactured by Advantage Medical Services, Inc.. The device is a Class 1 Anesthesiology device with product code FOG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K955482

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

FOG Device Classification - Class 1, General Controls

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.