Cleared Traditional

K925893 - OEM MEDICAL ADULT ANESTHESIA BREATHING ...

K925893 is the FDA 510(k) clearance for OEM MEDICAL ADULT ANESTHESIA BREATHING ... by Oem Medical Div.. It is a Class 1 Anesthesiology device (product code CAI) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K925893 · Oem Medical Div. · Anesthesiology device
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Mar 1993
Decision
115d
Days
Class 1
Risk

K925893 is an FDA 510(k) clearance for the OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Oem Medical Div. (Richmond, US). The FDA issued a Cleared decision on March 12, 1993 after a review of 115 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 Oem Medical Div. devices

Submission Details

510(k) Number K925893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1992
Decision Date March 12, 1993
Days to Decision 115 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
25d faster than avg
Panel avg: 140d · This submission: 115d
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 25
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K925893.
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
ADULT CIRCLE BREATH CIRCUIT W/INTERN GAS SAMP LINE
K905450 · Vital Signs, Inc. · Jul 1991