Cleared Traditional

K961707 - TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM (FDA 510(k) Clearance)

Class I Anesthesiology device.

K961707 · Sorenson Critical Care · Anesthesiology device
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Mar 1997
Decision
313d
Days
Class 1
Risk

K961707 is an FDA 510(k) clearance for the TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Sorenson Critical Care (Salt Lake City, US). The FDA issued a Cleared decision on March 11, 1997 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6810 - 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.

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Submission Details

510(k) Number K961707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1996
Decision Date March 11, 1997
Days to Decision 313 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
174d slower than avg
Panel avg: 139d · This submission: 313d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BSY Catheters, Suction, Tracheobronchial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6810
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.