Cleared Traditional

K940890 - CORRUGATED TUBING

K940890 is an FDA 510(k) clearance for CORRUGATED TUBING, manufactured by Cleveland Tubing, Inc.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K940890 · Cleveland Tubing, Inc. · Anesthesiology device
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Nov 1994
Decision
289d
Days
Class 1
Risk

K940890 is an FDA 510(k) clearance for the CORRUGATED TUBING. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Cleveland Tubing, Inc. (Cleveland, US). The FDA issued a Cleared decision on November 10, 1994 after a review of 289 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 Cleveland Tubing, Inc. devices

FDA 510(k) Submission Details - K940890

510(k) Number K940890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1994
Decision Date November 10, 1994
Days to Decision 289 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 140d · This submission: 289d
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 K940890.
PRIMA PEDIATRIC ANESTHESIA CIRCUITS
K952020 · Prima, Inc. · May 1995
PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K952009 · Prima, Inc. · May 1995
PRIMA, INC. ADULT ANESTHESIA CIRCUIT
K944533 · Prima, Inc. · Nov 1994
KARL STORZ LARYNGOSCOPE ACCESSORIES
K944295 · KARL STORZ Endoscopy-America, Inc. · Oct 1994
PEDIATRIC ANESTHESIA CIRCUITS
K942122 · Mag, Inc. · Jun 1994
M.A.G. INC. VENTILATOR HOSES
K942123 · Mag, Inc. · Jun 1994