Cleared Traditional

K963601 - MODEL 1920 WASTE GAS SCAVENGER

K963601 is the FDA 510(k) clearance for MODEL 1920 WASTE GAS SCAVENGER by G. Dundas Co.. It is a Class 2 Anesthesiology device (product code CBN) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K963601 · G. Dundas Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
231d
Days
Class 2
Risk

K963601 is an FDA 510(k) clearance for the MODEL 1920 WASTE GAS SCAVENGER. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by G. Dundas Co. (Black Diamond, US). The FDA issued a Cleared decision on April 28, 1997 after a review of 231 days - an extended review 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: 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. devices

Submission Details

510(k) Number K963601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1996
Decision Date April 28, 1997
Days to Decision 231 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 140d · This submission: 231d
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.

Regulatory Peers - CBN Apparatus, Gas-scavenging

Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K963601.
Nitronox Scavenger Plus
K223452 · Parker Hannifin Corporation · Mar 2023
Dynamic Gas Scavenging System 2 (DGSS - 2)
K193646 · Anesthetic Gas Reclamation, Inc. · Dec 2020
OPEN RESERVOIR SCAVENGER
K864034 · Draeger Medical, Inc. · Dec 1986
POSIVAC
K791127 · Vital Signs, Inc. · Jul 1979
NAD SCAVENGING RELIEF VALVE
K790333 · Draeger Medical, Inc. · Mar 1979