Cleared Traditional

K832793 - NEOCATH 1000 W/HEPCOTE

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

K832793 · Orange Medical Instruments, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K832793

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.

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 16
Devices cleared under the same product code (CCE) and FDA review panel - the closest regulatory comparables to K832793.
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
OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100
K853786 · American Bentley · Oct 1985
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