Cleared Special

K081691 - INOMAX DS (DELIVERY SYSTEM)

K081691 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 MRN cleared through the Special 510(k) pathway after a 72-day FDA review.

K081691 · Ino Therapeutics, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
72d
Days
Class 2
Risk

K081691 is an FDA 510(k) clearance for the INOMAX DS (DELIVERY SYSTEM). 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 August 28, 2008 after a review of 72 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 - K081691

510(k) Number K081691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2008
Decision Date August 28, 2008
Days to Decision 72 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
68d faster than avg
Panel avg: 140d · This submission: 72d
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 K081691.
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
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K080484 · Ino Therapeutics · Aug 2008
INOMAX DS
K071516 · Ino Therapeutics, LLC · Oct 2007
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K070867 · Ino Therapeutics, LLC · Apr 2007