Cleared Traditional

K875225 - UMBILICAL ARTERY OXYGEN SENSOR

K875225 is the FDA 510(k) clearance for UMBILICAL ARTERY OXYGEN SENSOR by Ohmeda Medical. It is a Class 2 Anesthesiology device (product code CCE) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K875225 · Ohmeda Medical · Anesthesiology device
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Mar 1988
Decision
73d
Days
Class 2
Risk

K875225 is an FDA 510(k) clearance for the UMBILICAL ARTERY OXYGEN SENSOR. Classified as Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (product code CCE), Class II - Special Controls.

Submitted by Ohmeda Medical (Tampa, US). The FDA issued a Cleared decision on March 4, 1988 after a review of 73 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 Ohmeda Medical devices

Submission Details

510(k) Number K875225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date March 04, 1988
Days to Decision 73 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
67d faster than avg
Panel avg: 140d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K875225.
NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY
K895149 · Shiley, Inc. · Nov 1989
CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING
K895150 · Shiley, Inc. · Nov 1989
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM
K884063 · C.R. Bard, Inc. · Dec 1988
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