Cleared Traditional

K925893 - OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT

K925893 is an FDA 510(k) clearance for OEM MEDICAL ADULT ANESTHESIA BREATHING ..., manufactured by Oem Medical Div.. The device is a Class 1 Anesthesiology device with 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

FDA 510(k) Submission Details - K925893

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.

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 117
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K925893.
CUSTOM ANESTHESIA CIRCUITS
K932197 · Life Shield Healthcare Products, Inc. · Jul 1993
ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON
K926454 · Medical, Inc. · Jun 1993
KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUIT
K922789 · King Systems Corp. · May 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
ANESTHESIA BREATHING CIRCUIT
K915452 · Concord/Portex · Feb 1992