Cleared Traditional

K063519 - DYNAMIC GAS SCAVENGING SYSTEM (DGSS)

K063519 is an FDA 510(k) clearance for DYNAMIC GAS SCAVENGING SYSTEM (DGSS), manufactured by Anesthetic Gas Reclamation, LLC. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K063519 · Anesthetic Gas Reclamation, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
10d
Days
Class 2
Risk

K063519 is an FDA 510(k) clearance for the DYNAMIC GAS SCAVENGING SYSTEM (DGSS). Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Anesthetic Gas Reclamation, LLC (Nashville, US). The FDA issued a Cleared decision on December 1, 2006 after a review of 10 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K063519

510(k) Number K063519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2006
Decision Date December 01, 2006
Days to Decision 10 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 140d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Citech
ROBERT MOSENKIS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CBN Apparatus, Gas-scavenging

All 25
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K063519.
VAPOR-CLEAR, MODEL 100
K092031 · Axon Medical, Inc. · Apr 2010
PASSIVE WASTE GAS SCAVENGER, MODEL 14600
K080039 · G. Dundas Co.,Inc. · Apr 2008
MINRAD INC. NASAL SCAVENGING CIRCUIT
K072255 · Minrad, Inc. · Oct 2007
ANEFIN, MODEL 100
K033028 · Axon Medical · Jul 2005
RFS VACUUM GAUGE SCAVENGING CIRCUIT
K033503 · Accutron, Inc. · Mar 2004
AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000
K981754 · Porter Instrument Co., Inc. · Jun 1998