Cleared Traditional

K880683 - KING SYSTEMS

K880683 is an FDA 510(k) clearance for KING SYSTEMS, manufactured by King Systems Corp.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K880683 · King Systems Corp. · Anesthesiology device
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Mar 1988
Decision
19d
Days
Class 1
Risk

K880683 is an FDA 510(k) clearance for the KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUIT. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on March 9, 1988 after a review of 19 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 King Systems Corp. devices

FDA 510(k) Submission Details - K880683

510(k) Number K880683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1988
Decision Date March 09, 1988
Days to Decision 19 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 140d · This submission: 19d
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 71
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K880683.
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