Cleared Traditional

K930713 - THE INFANT FLOW SYSTEM

K930713 is an FDA 510(k) clearance for THE INFANT FLOW SYSTEM, manufactured by Sechrist Industries, Inc.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K930713 · Sechrist Industries, Inc. · Anesthesiology device
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Sep 1993
Decision
217d
Days
Class 1
Risk

K930713 is an FDA 510(k) clearance for the THE INFANT FLOW SYSTEM. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Sechrist Industries, Inc. (Anaheim, US). The FDA issued a Cleared decision on September 16, 1993 after a review of 217 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 Sechrist Industries, Inc. devices

FDA 510(k) Submission Details - K930713

510(k) Number K930713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1993
Decision Date September 16, 1993
Days to Decision 217 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
77d slower than avg
Panel avg: 140d · This submission: 217d
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 K930713.
M.A.G. INC PEDIATRIC TEMPERATURE MONITORING CIRCUITS
K942136 · Mag, Inc. · Jun 1994
ADULT ANESTHESIA BREATHING CIRCUIT
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MAPLESON D CIRCUIT
K942570 · Med-Plastics Intl., Inc. · Jun 1994
GAS SAMPLING LINES AND CONNECTORS
K932562 · Life Shield Healthcare Products, Inc. · Jul 1993
ADULT ANESTHESIA BREATHING CIRCUIT
K932707 · Precision Med Products, Ltd. · Jul 1993
PRECISION MED PRODUCTS LTD MAPLESON D CIRCUITS
K932708 · Precision Med Products, Ltd. · Jul 1993