Cleared Traditional

K912504 - DISPOSABLE ANESTHESIA BREATHING CIRCUITS

K912504 is an FDA 510(k) clearance for DISPOSABLE ANESTHESIA BREATHING CIRCUITS, manufactured by Intertech Resources, Inc.. The device is a Class 1 Anesthesiology device with product code CAI cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K912504 · Intertech Resources, Inc. · Anesthesiology device
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Oct 1991
Decision
140d
Days
Class 1
Risk

K912504 is an FDA 510(k) clearance for the DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on October 23, 1991 after a review of 140 days - within the typical 510(k) review window.

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 Intertech Resources, Inc. devices

FDA 510(k) Submission Details - K912504

510(k) Number K912504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1991
Decision Date October 23, 1991
Days to Decision 140 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
At panel average
Panel avg: 140d · This submission: 140d
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 43
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K912504.
MERIDIAN MEDICAL SYSTEMS MAPLESON D CIRCUITS
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MERIDIAN MEDICAL SYSTEMS ADULT ANES BREATH CIRCUIT
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DISPOSABLE ANESTHESIA BREATHING CIRCUITS, MODIFIED
K912065 · Intertech Resources, Inc. · Oct 1991
22MM ID/OD ADAPTER
K911263 · Monaghan Medical Corp. · Aug 1991
ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE
K905450 · Vital Signs, Inc. · Jul 1991
BABYFLEX HEATED INFANT BREATHING CIRCUIT
K896365 · Baxter Healthcare Corp · Jan 1990