Cleared Traditional

K896897 - VENTLAB ANESTHESIA CIRCUIT AC 6000

K896897 is an FDA 510(k) clearance for VENTLAB ANESTHESIA CIRCUIT AC 6000, manufactured by Ventlab Corp.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K896897 · Ventlab Corp. · Anesthesiology device
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Jan 1990
Decision
49d
Days
Class 1
Risk

K896897 is an FDA 510(k) clearance for the VENTLAB ANESTHESIA CIRCUIT AC 6000. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Ventlab Corp. (Hackensack, US). The FDA issued a Cleared decision on January 26, 1990 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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 Ventlab Corp. devices

FDA 510(k) Submission Details - K896897

510(k) Number K896897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1989
Decision Date January 26, 1990
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 140d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

CAI Device Classification - Class 1, General Controls

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
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.

Regulatory Peers - CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)

All 54
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K896897.
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