Cleared Traditional

K895479 - THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM (FDA 510(k) Clearance)

Class I Anesthesiology device.

K895479 · Thayer Medical Corp. · Anesthesiology device
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Mar 1990
Decision
179d
Days
Class 1
Risk

K895479 is an FDA 510(k) clearance for the THAYER SEMI-RIGID CONDENSATE COLLECTION SYSTEM. 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 March 9, 1990 after a review of 179 days - an extended review cycle.

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 K895479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1989
Decision Date March 09, 1990
Days to Decision 179 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 139d · This submission: 179d
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.