Cleared Traditional

K902093 - RESU-GARD CATHETER SUCTION (FDA 510(k) Clearance)

Class I Anesthesiology device.

K902093 · Amg Medical Equipments, Inc. · Anesthesiology device
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Oct 1990
Decision
167d
Days
Class 1
Risk

K902093 is an FDA 510(k) clearance for the RESU-GARD CATHETER SUCTION. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Amg Medical Equipments, Inc. (Elk Grove, US). The FDA issued a Cleared decision on October 23, 1990 after a review of 167 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 Amg Medical Equipments, Inc. devices

Submission Details

510(k) Number K902093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1990
Decision Date October 23, 1990
Days to Decision 167 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 139d · This submission: 167d
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.