Cleared Traditional

K940793 - DOUBLE TRACH SWIVEL CONNECTOR (FDA 510(k) Clearance)

Class I Anesthesiology device.

K940793 · Seven Harvest Intl. Import & Export · Anesthesiology device
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Jul 1994
Decision
129d
Days
Class 1
Risk

K940793 is an FDA 510(k) clearance for the DOUBLE TRACH SWIVEL CONNECTOR. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Seven Harvest Intl. Import & Export (Tipton, US). The FDA issued a Cleared decision on July 1, 1994 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5810 - 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.

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Submission Details

510(k) Number K940793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1994
Decision Date July 01, 1994
Days to Decision 129 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
10d faster than avg
Panel avg: 139d · This submission: 129d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZA Connector, Airway (extension)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5810
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.