Cleared Traditional

K900047 - THAYER SUCTION EVACUATION CONDENSATE COLLECTION (FDA 510(k) Clearance)

Class I Anesthesiology device.

K900047 · Thayer Medical Corp. · Anesthesiology device
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Apr 1990
Decision
110d
Days
Class 1
Risk

K900047 is an FDA 510(k) clearance for the THAYER SUCTION EVACUATION CONDENSATE COLLECTION. Classified as Drain, Tee (water Trap) (product code BYH), Class I - General Controls.

Submitted by Thayer Medical Corp. (Tucson, US). The FDA issued a Cleared decision on April 23, 1990 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5995 - 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 Thayer Medical Corp. devices

Submission Details

510(k) Number K900047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1990
Decision Date April 23, 1990
Days to Decision 110 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 139d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BYH Drain, Tee (water Trap)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5995
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.