Cleared Special

K090958 - INOMAX DS (DELIVERY SYSTEM)

K090958 is an FDA 510(k) clearance for INOMAX DS (DELIVERY SYSTEM), manufactured by Ino Therapeutics, LLC. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Special 510(k) pathway after a 73-day FDA review.

K090958 · Ino Therapeutics, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
73d
Days
Class 2
Risk

K090958 is an FDA 510(k) clearance for the INOMAX DS (DELIVERY SYSTEM). Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Ino Therapeutics, LLC (Madison, US). The FDA issued a Cleared decision on June 18, 2009 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K090958

510(k) Number K090958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2009
Decision Date June 18, 2009
Days to Decision 73 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 140d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

MNR Device Classification - Class 2, Special Controls

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - MNR Ventilatory Effort Recorder

All 162
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