Cleared Traditional

K963601 - MODEL 1920 WASTE GAS SCAVENGER

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

K963601 · G. Dundas Co. · Anesthesiology device
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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

FDA 510(k) Submission Details - K963601

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
Combination Product No
PCCP Authorized No
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.

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 19
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K963601.
ISO-GARD CLEARAIR MASK
K123176 · Teleflexmedical, Inc. · Feb 2013
ACTIVE WASTE GAS SCAVENGER
K110930 · G. Dundas Co.,Inc. · Jun 2011
AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000
K981754 · Porter Instrument Co., Inc. · Jun 1998
PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U)
K965239 · Accutron, Inc. · Mar 1997
SAFECIRCUIT MANIFOLD/PULMONARY UNIT
K953269 · Advanced Warming Systems, Inc. · Dec 1996
RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963
K893532 · Medipart Jerry Alexander · Aug 1989