Not Cleared Post-NSE

DEN000001 - OHMEDA INOVENT DELIVERY SYSTEM

DEN000001 is an FDA 510(k) submission for OHMEDA INOVENT DELIVERY SYSTEM, manufactured by Ohmeda Medical. The device is a Class 2 Anesthesiology device with 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.

FDA 510(k) Submission Details - DEN000001

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

MRN Device Classification - Class 2, Special Controls

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 33
Devices cleared under the same product code (MRN) and FDA review panel - the closest regulatory comparables to DEN000001.
VIANOX DELIVERY SYSTEM, MODEL II
K033779 · Pulmonox Medical, Inc. · Jan 2004
AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002
K000653 · Pulmonox Medical Corp. · Aug 2000
DATEX-OHMEDA INOVENT DELIVERY SYSTEM
K000186 · Datex-Ohmeda · Feb 2000
DEN000001 · OHMEDA INOVENT DELIVERY SYSTEM
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