Cleared Traditional

K955721 - CUFFED OROPHARYNGEAL AIRWAY (COPA) (FDA 510(k) Clearance)

Class I Anesthesiology device.

K955721 · Mallinckrodt Medical · Anesthesiology device
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Mar 1997
Decision
466d
Days
Class 1
Risk

K955721 is an FDA 510(k) clearance for the CUFFED OROPHARYNGEAL AIRWAY (COPA). Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 466 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5110 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

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Submission Details

510(k) Number K955721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1995
Decision Date March 28, 1997
Days to Decision 466 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
327d slower than avg
Panel avg: 139d · This submission: 466d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAE Airway, Oropharyngeal, Anesthesiology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5110
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.