Cleared Traditional

K942568 - ADULT ANESTHESIA BREATHING CIRCUIT

K942568 is an FDA 510(k) clearance for ADULT ANESTHESIA BREATHING CIRCUIT, manufactured by Med-Plastics Intl., Inc.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K942568 · Med-Plastics Intl., Inc. · Anesthesiology device
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Jun 1994
Decision
10d
Days
Class 1
Risk

K942568 is an FDA 510(k) clearance for the ADULT ANESTHESIA BREATHING CIRCUIT. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Med-Plastics Intl., Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 10, 1994 after a review of 10 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 Med-Plastics Intl., Inc. devices

FDA 510(k) Submission Details - K942568

510(k) Number K942568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1994
Decision Date June 10, 1994
Days to Decision 10 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 140d · This submission: 10d
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 116
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K942568.
M.A.G. INC. BREALTHING BAGS
K942134 · Mag, Inc. · Jun 1994
M.A.G. INC. COAXIAL CIRCUITS
K942135 · Mag, Inc. · Jun 1994
M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K942136 · Mag, Inc. · Jun 1994
MAPLESON D CIRCUIT
K942570 · Med-Plastics Intl., Inc. · Jun 1994
THE INFANT FLOW SYSTEM
K930713 · Sechrist Industries, Inc. · Sep 1993
GAS SAMPLING LINES AND CONNECTORS
K932562 · Life Shield Healthcare Products, Inc. · Jul 1993