Cleared Special

K080484 - INOMAX DS (DELIVERY SYSTEM), MODEL 10003

K080484 is an FDA 510(k) clearance for INOMAX DS (DELIVERY SYSTEM), manufactured by Ino Therapeutics. The device is a Class 2 Anesthesiology device with product code MRN cleared through the Special 510(k) pathway after a 166-day FDA review.

K080484 · Ino Therapeutics · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
166d
Days
Class 2
Risk

K080484 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 (Clinton, US). The FDA issued a Cleared decision on August 6, 2008 after a review of 166 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.

FDA 510(k) Submission Details - K080484

510(k) Number K080484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2008
Decision Date August 06, 2008
Days to Decision 166 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
26d slower than avg
Panel avg: 140d · This submission: 166d
Pathway characteristics
Modification to existing cleared device.

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 32
Devices cleared under the same product code (MRN) and FDA review panel - the closest regulatory comparables to K080484.
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K092545 · Ino Therapeutics, LLC · Mar 2010
AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM
K093260 · International Biomedical, Ltd. · Dec 2009
INOMAX DS (DELIVERY SYSTEM)
K081691 · Ino Therapeutics, LLC · Aug 2008
INOMAX DS
K071516 · Ino Therapeutics, LLC · Oct 2007
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K070867 · Ino Therapeutics, LLC · Apr 2007
INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K061901 · Ino Therapeutics · Dec 2006