Not Cleared Post-NSE

DEN000001 - OHMEDA INOVENT DELIVERY SYSTEM (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

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.

View all Ohmeda Medical devices

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
135d faster than avg
Panel avg: 139d · 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.

Regulatory Peers - MRN Apparatus, Nitric Oxide Delivery

All 32
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