Cleared Special

K122689 - INOBLENDER

K122689 is an FDA 510(k) clearance for INOBLENDER, manufactured by Ino Therapeutics. The device is a Class 2 Anesthesiology device with product code MRO cleared through the Special 510(k) pathway after a 64-day FDA review.

K122689 · Ino Therapeutics · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
64d
Days
Class 2
Risk

K122689 is an FDA 510(k) clearance for the INOBLENDER. Classified as Apparatus, Nitric Oxide, Backup Delivery (product code MRO), Class II - Special Controls.

Submitted by Ino Therapeutics (Madison, US). The FDA issued a Cleared decision on November 7, 2012 after a review of 64 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 - K122689

510(k) Number K122689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2012
Decision Date November 07, 2012
Days to Decision 64 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
76d faster than avg
Panel avg: 140d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

MRO Device Classification - Class 2, Special Controls

Product Code MRO Apparatus, Nitric Oxide, Backup 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.