Cleared Traditional

K895149 - NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K895149 · Shiley, Inc. · Anesthesiology device
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Nov 1989
Decision
97d
Days
Class 2
Risk

K895149 is an FDA 510(k) clearance for the NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY. Classified as Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (product code CCE), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on November 28, 1989 after a review of 97 days - within the typical 510(k) review window.

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: 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 Shiley, Inc. devices

Submission Details

510(k) Number K895149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1989
Decision Date November 28, 1989
Days to Decision 97 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 139d · This submission: 97d
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.