Cleared Special

K033503 - RFS VACUUM GAUGE SCAVENGING CIRCUIT

K033503 is an FDA 510(k) clearance for RFS VACUUM GAUGE SCAVENGING CIRCUIT, manufactured by Accutron, Inc.. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Special 510(k) pathway after a 128-day FDA review.

K033503 · Accutron, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
128d
Days
Class 2
Risk

K033503 is an FDA 510(k) clearance for the RFS VACUUM GAUGE SCAVENGING CIRCUIT. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Accutron, Inc. (Golden, US). The FDA issued a Cleared decision on March 12, 2004 after a review of 128 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K033503

510(k) Number K033503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2003
Decision Date March 12, 2004
Days to Decision 128 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
12d faster than avg
Panel avg: 140d · This submission: 128d
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 K033503.
MINRAD INC. NASAL SCAVENGING CIRCUIT
K072255 · Minrad, Inc. · Oct 2007
DYNAMIC GAS SCAVENGING SYSTEM (DGSS)
K063519 · Anesthetic Gas Reclamation, LLC · Dec 2006
ANEFIN, MODEL 100
K033028 · Axon Medical · Jul 2005
AUTOMATIC VACUUM SWITCH (AVS) MODEL NUMBER AVS 5000
K981754 · Porter Instrument Co., Inc. · Jun 1998
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