Cleared Special

K071516 - INOMAX DS

K071516 is an FDA 510(k) clearance for INOMAX DS, 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 121-day FDA review.

K071516 · Ino Therapeutics, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
121d
Days
Class 2
Risk

K071516 is an FDA 510(k) clearance for the INOMAX DS. Classified as Apparatus, Nitric Oxide Delivery (product code MRN), Class II - Special Controls.

Submitted by Ino Therapeutics, LLC (Clinton, US). The FDA issued a Cleared decision on October 3, 2007 after a review of 121 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 - K071516

510(k) Number K071516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2007
Decision Date October 03, 2007
Days to Decision 121 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
19d faster than avg
Panel avg: 140d · This submission: 121d
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 K071516.
AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM
K093260 · International Biomedical, Ltd. · Dec 2009
INOMAX DS (DELIVERY SYSTEM)
K081691 · Ino Therapeutics, LLC · Aug 2008
INOMAX DS (DELIVERY SYSTEM), MODEL 10003
K080484 · Ino Therapeutics · Aug 2008
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
VIANOX DELIVERY SYSTEM, MODEL II
K033779 · Pulmonox Medical, Inc. · Jan 2004