Cleared Traditional

K890438 - GAS-VAK(R), MODEL 300

K890438 is an FDA 510(k) clearance for GAS-VAK, manufactured by Gas-Vak. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K890438 · Gas-Vak · Anesthesiology device
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Aug 1989
Decision
188d
Days
Class 2
Risk

K890438 is an FDA 510(k) clearance for the GAS-VAK(R), MODEL 300. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Gas-Vak (Westwood, US). The FDA issued a Cleared decision on August 7, 1989 after a review of 188 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 Gas-Vak devices

FDA 510(k) Submission Details - K890438

510(k) Number K890438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1989
Decision Date August 07, 1989
Days to Decision 188 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 140d · This submission: 188d
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 K890438.
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
OHIO WASTE GAS SCAVENGING RESERVOIR
K841733 · Ohio Medical Products · Jul 1984