Cleared Traditional

K832793 - NEOCATH 1000 W/HEPCOTE

K832793 is the FDA 510(k) clearance for NEOCATH 1000 W/HEPCOTE by Orange Medical Instruments, Inc.. It is a Class 2 Anesthesiology device (product code CCE) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K832793 · Orange Medical Instruments, Inc. · Anesthesiology device
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Sep 1983
Decision
38d
Days
Class 2
Risk

K832793 is an FDA 510(k) clearance for the NEOCATH 1000 W/HEPCOTE. Classified as Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (product code CCE), Class II - Special Controls.

Submitted by Orange Medical Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on September 26, 1983 after a review of 38 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 Orange Medical Instruments, Inc. devices

Submission Details

510(k) Number K832793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1983
Decision Date September 26, 1983
Days to Decision 38 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 140d · This submission: 38d
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.