Cleared Special

K092545 - INOMAX DS (DELIVERY SYSTEM), MODEL 10003 (FDA 510(k) Clearance)

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

K092545 · Ino Therapeutics, LLC · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Mar 2010
Decision
203d
Days
Class 2
Risk

K092545 is an FDA 510(k) clearance for the INOMAX DS (DELIVERY SYSTEM), MODEL 10003. Classified as Apparatus, Nitric Oxide Delivery (product code MRN), Class II - Special Controls.

Submitted by Ino Therapeutics, LLC (Madison, US). The FDA issued a Cleared decision on March 10, 2010 after a review of 203 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5165 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ino Therapeutics, LLC devices

Submission Details

510(k) Number K092545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2009
Decision Date March 10, 2010
Days to Decision 203 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 139d · This submission: 203d
Pathway characteristics
Modification to existing cleared device.

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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