Cleared Traditional

XTEND CIRCUITS (TM) (K924627) - FDA 510(k) Clearance

Class I Anesthesiology device.

K924627 · Arc Medical, Inc. · Anesthesiology device
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Apr 1993
Decision
205d
Days
Class 1
Risk

K924627 is an FDA 510(k) clearance for the XTEND CIRCUITS (TM). Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Arc Medical, Inc. (Clarkston, US). The FDA issued a Cleared decision on April 7, 1993 after a review of 205 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 Arc Medical, Inc. devices

Submission Details

510(k) Number K924627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1992
Decision Date April 07, 1993
Days to Decision 205 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
65d slower than avg
Panel avg: 140d · This submission: 205d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 14
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K924627.
PEDIATRIC ANESTHESIA CIRCUITS
K932585 · Merit Medical Systems, Inc. · Jul 1993
CUSTOM ANESTHESIA CIRCUITS
K932586 · Merit Medical Systems, Inc. · Jul 1993
COAXIAL CIRCUITS
K932587 · Merit Medical Systems, Inc. · Jul 1993
MERIDIAN MEDICAL SYSTEMS MAPLESON D CIRCUITS
K925231 · Merit Medical Systems, Inc. · Jan 1993
MERIDIAN MEDICAL SYSTEMS ADULT ANES BREATH CIRCUIT
K925232 · Merit Medical Systems, Inc. · Jan 1993
BABYFLEX HEATED INFANT BREATHING CIRCUIT
K896365 · Baxter Healthcare Corp · Jan 1990