Cleared Traditional

K920043 - AIRES

K920043 is an FDA 510(k) clearance for AIRES, manufactured by Viva-Tek Assoc., Inc.. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 527-day FDA review.

K920043 · Viva-Tek Assoc., Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
527d
Days
Class 2
Risk

K920043 is an FDA 510(k) clearance for the AIRES. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Viva-Tek Assoc., Inc. (Medford, US). The FDA issued a Cleared decision on June 16, 1993 after a review of 527 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Viva-Tek Assoc., Inc. devices

FDA 510(k) Submission Details - K920043

510(k) Number K920043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1992
Decision Date June 16, 1993
Days to Decision 527 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
387d slower than avg
Panel avg: 140d · This submission: 527d
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 24
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K920043.
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
RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963
K893532 · Medipart Jerry Alexander · Aug 1989
OPEN RESERVOIR SCAVENGER
K864034 · Draeger Medical, Inc. · Dec 1986
GAS EVACUATION ACCESSORY
K852772 · Siemens Elema AB · Oct 1985