Cleared Special

Dynamic Gas Scavenging System 2 (DGSS - 2) (K193646) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K193646 · Anesthetic Gas Reclamation, Inc. · Anesthesiology device
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Dec 2020
Decision
340d
Days
Class 2
Risk

K193646 is an FDA 510(k) clearance for the Dynamic Gas Scavenging System 2 (DGSS - 2). Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Anesthetic Gas Reclamation, Inc. (Dallas, US). The FDA issued a Cleared decision on December 4, 2020 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5430 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Anesthetic Gas Reclamation, Inc. devices

Submission Details

510(k) Number K193646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2019
Decision Date December 04, 2020
Days to Decision 340 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 139d · This submission: 340d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Consultant

Ceutical Laboratories, Inc.
Laurel Arrigona

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.