Cleared Special

K110635 - INOMAX DS(IR) (DELIVERY SYSTEM)

K110635 is an FDA 510(k) clearance for INOMAX DS(IR) (DELIVERY SYSTEM), manufactured by Ino Therapeutics, LLC/Dba Ikaria. The device is a Class 2 Anesthesiology device with product code MRN cleared through the Special 510(k) pathway after a 111-day FDA review.

K110635 · Ino Therapeutics, LLC/Dba Ikaria · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
111d
Days
Class 2
Risk

K110635 is an FDA 510(k) clearance for the INOMAX DS(IR) (DELIVERY SYSTEM). Classified as Apparatus, Nitric Oxide Delivery (product code MRN), Class II - Special Controls.

Submitted by Ino Therapeutics, LLC/Dba Ikaria (Port Allen, US). The FDA issued a Cleared decision on June 23, 2011 after a review of 111 days - within the typical 510(k) review window.

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 - K110635

510(k) Number K110635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2011
Decision Date June 23, 2011
Days to Decision 111 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 140d · This submission: 111d
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 K110635.
GENOSYL MV-1000
K120216 · Geno, LLC · May 2012
INOMAX DS(DELIVERY SYSTEMS
K113272 · Ino Therapeutics, LLC/Dba Ikaria · Feb 2012
INOMAX DSIR (DELIVERY SYSTEM)
K110344 · Ino Therapeutics · Jun 2011
INOMAX DS
K093922 · Ino Therapeutics · Apr 2010
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K092545 · Ino Therapeutics, LLC · Mar 2010
AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM
K093260 · International Biomedical, Ltd. · Dec 2009