Cleared Traditional

K922843 - DYNAREX SUCTION CATHETERS & KITS (FDA 510(k) Clearance)

Class I Anesthesiology device.

K922843 · Dynarex Corp. · Anesthesiology device
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Jan 1993
Decision
213d
Days
Class 1
Risk

K922843 is an FDA 510(k) clearance for the DYNAREX SUCTION CATHETERS & KITS. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Dynarex Corp. (Brewster, US). The FDA issued a Cleared decision on January 11, 1993 after a review of 213 days - an extended review cycle.

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. 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 Dynarex Corp. devices

Submission Details

510(k) Number K922843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1992
Decision Date January 11, 1993
Days to Decision 213 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
74d slower than avg
Panel avg: 139d · This submission: 213d
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.