Cleared Traditional

K900428 - ANESTHESIA BREATHING CIRCUITS

K900428 is an FDA 510(k) clearance for ANESTHESIA BREATHING CIRCUITS, manufactured by Med-Tek Corp.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K900428 · Med-Tek Corp. · Anesthesiology device
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Aug 1990
Decision
199d
Days
Class 1
Risk

K900428 is an FDA 510(k) clearance for the ANESTHESIA BREATHING CIRCUITS. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Med-Tek Corp. (Glendale, US). The FDA issued a Cleared decision on August 17, 1990 after a review of 199 days - an extended review 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: 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 Med-Tek Corp. devices

FDA 510(k) Submission Details - K900428

510(k) Number K900428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1990
Decision Date August 17, 1990
Days to Decision 199 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 140d · This submission: 199d
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 117
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K900428.
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