Cleared Traditional

K830056 - ARTEC TWIST VALVE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K830056 · Artec Environmental Monitoring Division · Anesthesiology device
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Mar 1983
Decision
62d
Days
Class 1
Risk

K830056 is an FDA 510(k) clearance for the ARTEC TWIST VALVE. Classified as Bag, Reservoir (product code BTC), Class I - General Controls.

Submitted by Artec Environmental Monitoring Division (Walker, US). The FDA issued a Cleared decision on March 9, 1983 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5320 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Artec Environmental Monitoring Division devices

Submission Details

510(k) Number K830056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1983
Decision Date March 09, 1983
Days to Decision 62 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 139d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BTC Bag, Reservoir
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5320
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.