Cleared Traditional

K872113 - OMNI-VENT, SERIES D

K872113 is an FDA 510(k) clearance for OMNI-VENT, manufactured by Stein-Gates Medical Equipment, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K872113 · Stein-Gates Medical Equipment, Inc. · Anesthesiology device
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Mar 1988
Decision
296d
Days
Class 2
Risk

K872113 is an FDA 510(k) clearance for the OMNI-VENT, SERIES D. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Stein-Gates Medical Equipment, Inc. (Atchison, US). The FDA issued a Cleared decision on March 23, 1988 after a review of 296 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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.

FDA 510(k) Submission Details - K872113

510(k) Number K872113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1987
Decision Date March 23, 1988
Days to Decision 296 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 140d · This submission: 296d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 454
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K872113.
MODEL 7200A, PRESSURE VENTILATION OPTION
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K880054 · Ohmeda Medical · Apr 1988
6400ST INTERFACE MODULE-RS232
K880721 · Bird Products Corp. · Apr 1988
GAMBRO-ENGSTROM ERICA IV RESPIRATOR
K872482 · Gambro, Inc. · Mar 1988
COMPANION 2800A PORTABLE VENTILATOR - MODIFICATION
K873215 · Puritan Bennett Corp. · Jan 1988
UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR
K870861 · Impact Instrumentation, Inc. · Jan 1988
K872113 · OMNI-VENT, SERIES D
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