Cleared Special

K981754 - AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000

K981754 is an FDA 510(k) clearance for AUTOMATIC VACUUM SWITCH (AVS) MODEL NUM..., manufactured by Porter Instrument Co., Inc.. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Special 510(k) pathway after a 29-day FDA review.

K981754 · Porter Instrument Co., Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
29d
Days
Class 2
Risk

K981754 is an FDA 510(k) clearance for the AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Porter Instrument Co., Inc. (Hatfield, US). The FDA issued a Cleared decision on June 16, 1998 after a review of 29 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K981754

510(k) Number K981754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1998
Decision Date June 16, 1998
Days to Decision 29 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
111d faster than avg
Panel avg: 140d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 25
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K981754.
DYNAMIC GAS SCAVENGING SYSTEM (DGSS)
K063519 · Anesthetic Gas Reclamation, LLC · Dec 2006
ANEFIN, MODEL 100
K033028 · Axon Medical · Jul 2005
RFS VACUUM GAUGE SCAVENGING CIRCUIT
K033503 · Accutron, Inc. · Mar 2004
MODEL 1920 WASTE GAS SCAVENGER
K963601 · G. Dundas Co. · Apr 1997
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