Not Cleared Post-NSE

DEN000001 - OHMEDA INOVENT DELIVERY SYSTEM

DEN000001 is the FDA 510(k) submission for OHMEDA INOVENT DELIVERY SYSTEM by Ohmeda Medical. It is a Class 2 Anesthesiology device (product code MRN) cleared through the Post-NSE 510(k) pathway after a 4-day FDA review.

DEN000001 · Ohmeda Medical · Anesthesiology device
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Jan 2000
Decision
4d
Days
Class 2
Risk

DEN000001 is an FDA 510(k) submission (not cleared) for the OHMEDA INOVENT DELIVERY SYSTEM. Classified as Apparatus, Nitric Oxide Delivery (product code MRN), Class II - Special Controls.

Submitted by Ohmeda Medical (Madison, US). The FDA issued a Not Cleared (DENG) decision on January 11, 2000 after a review of 4 days.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5165 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Anesthesiology review framework.

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Submission Details

510(k) Number DEN000001 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 07, 2000
Decision Date January 11, 2000
Days to Decision 4 days
Submission Type Post-NSE
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d faster than avg
Panel avg: 140d · This submission: 4d
Pathway characteristics

Device Classification

Product Code MRN Apparatus, Nitric Oxide Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5165
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.