Cleared Traditional

K080039 - PASSIVE WASTE GAS SCAVENGER

K080039 is an FDA 510(k) clearance for PASSIVE WASTE GAS SCAVENGER, manufactured by G. Dundas Co.,Inc.. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K080039 · G. Dundas Co.,Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K080039

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
42d faster than avg
Panel avg: 140d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBN Device Classification - Class 2, Special Controls

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.

Regulatory Peers - CBN Apparatus, Gas-scavenging

All 14
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K080039.
ISO-GARD MASK
K142138 · Teleflexmedical, Inc. · Oct 2014
ISO-GARD MASK
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ISO-GARD CLEARAIR MASK
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K893532 · Medipart Jerry Alexander · Aug 1989
OPEN RESERVOIR SCAVENGER
K864034 · Draeger Medical, Inc. · Dec 1986
GAS EVACUATION ACCESSORY
K852772 · Siemens Elema AB · Oct 1985