Cleared Traditional

K063519 - DYNAMIC GAS SCAVENGING SYSTEM (DGSS) (FDA 510(k) Clearance)

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

K063519 · Anesthetic Gas Reclamation, LLC · Anesthesiology device
Download Printable Device Report (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.

View all Anesthetic Gas Reclamation, LLC devices

Submission Details

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
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 139d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.