Cleared Traditional

K860808 - CONTINUCATH

K860808 is an FDA 510(k) clearance for CONTINUCATH, 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 9-day FDA review.

K860808 · Orange Medical Instruments, Inc. · Anesthesiology device
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Mar 1986
Decision
9d
Days
Class 2
Risk

K860808 is an FDA 510(k) clearance for the CONTINUCATH. Classified as Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (product code CCE), Class II - Special Controls.

Submitted by Orange Medical Instruments, Inc. (Buckinghamshire, England, GB). The FDA issued a Cleared decision on March 13, 1986 after a review of 9 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 - K860808

510(k) Number K860808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date March 13, 1986
Days to Decision 9 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 140d · This submission: 9d
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 K860808.
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