Cleared Traditional

K853786 - OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100

K853786 is an FDA 510(k) clearance for OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100, manufactured by American Bentley. The device is a Class 2 Anesthesiology device with product code CCE cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K853786 · American Bentley · Anesthesiology device
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Oct 1985
Decision
36d
Days
Class 2
Risk

K853786 is an FDA 510(k) clearance for the OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100. Classified as Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (product code CCE), Class II - Special Controls.

Submitted by American Bentley (Irvine, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1200 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Bentley devices

FDA 510(k) Submission Details - K853786

510(k) Number K853786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1985
Decision Date October 16, 1985
Days to Decision 36 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 140d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCE Device Classification - Class 2, Special Controls

Product Code CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1200
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 - CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling

All 14
Devices cleared under the same product code (CCE) and FDA review panel - the closest regulatory comparables to K853786.
UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100
K872896 · American Bentley · Feb 1988
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM
K872125 · C.R. Bard, Inc. · Dec 1987
OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100
K860106 · American Bentley · Feb 1986
VENOUS OXYGEN PROBE
K811071 · G.D. Searle and Co. · May 1981
CATHETER, PO2, INTRAVASUCLAR, CITADEL
K771116 · Sherwood Medical Industries · Sep 1977
MONITOR, CITADEL INTRAVASCULAR PO2
K760350 · Sherwood Medical Industries · Oct 1976