Cleared Special

K130605 - INOMAX DSIR (DELIVERY SYSTEM)

K130605 is an FDA 510(k) clearance for INOMAX DSIR (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 56-day FDA review.

K130605 · Ino Therapeutics · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
56d
Days
Class 2
Risk

K130605 is an FDA 510(k) clearance for the INOMAX DSIR (DELIVERY SYSTEM). Classified as Apparatus, Nitric Oxide Delivery (product code MRN), Class II - Special Controls.

Submitted by Ino Therapeutics (Madison, US). The FDA issued a Cleared decision on May 2, 2013 after a review of 56 days - a notably fast clearance 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. 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 - K130605

510(k) Number K130605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2013
Decision Date May 02, 2013
Days to Decision 56 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
84d faster than avg
Panel avg: 140d · This submission: 56d
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 K130605.
NOxBOXi Nitric Oxide Delivery System
K171696 · Praxair Distribution, Inc. · Oct 2018
INOmax DSIR Plus MRI
K143213 · Ino Therapeutics/Ikaria · Jul 2015
INOMAX DSIR (DELIVERY SYSTEM)
K131686 · Ino Therapeutics/Ikaria · Nov 2013
INOMAX DS (DELIVERY SYSTEM)
K121021 · Ino Therapeutics · Sep 2012
GENOSYL MV-1000
K120216 · Geno, LLC · May 2012
INOMAX DS(DELIVERY SYSTEMS
K113272 · Ino Therapeutics, LLC/Dba Ikaria · Feb 2012