Cleared Traditional

K080039 - PASSIVE WASTE GAS SCAVENGER, MODEL 14600 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080039 · G. Dundas Co.,Inc. · Anesthesiology device
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Apr 2008
Decision
98d
Days
Class 2
Risk

K080039 is an FDA 510(k) clearance for the PASSIVE WASTE GAS SCAVENGER, MODEL 14600. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by G. Dundas Co.,Inc. (Black Diamond, US). The FDA issued a Cleared decision on April 14, 2008 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5430 - 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 G. Dundas Co.,Inc. devices

Submission Details

510(k) Number K080039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2008
Decision Date April 14, 2008
Days to Decision 98 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
41d faster than avg
Panel avg: 139d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBN Apparatus, Gas-scavenging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5430
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.