Cleared Special

K052663 - INO THERAPEUTICS INOBLENDER, MODEL 10004 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K052663 · Ino Therapeutics · Anesthesiology device
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Nov 2005
Decision
38d
Days
Class 2
Risk

K052663 is an FDA 510(k) clearance for the INO THERAPEUTICS INOBLENDER, MODEL 10004. Classified as Apparatus, Nitric Oxide, Backup Delivery (product code MRO), Class II - Special Controls.

Submitted by Ino Therapeutics (Middleton, US). The FDA issued a Cleared decision on November 4, 2005 after a review of 38 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.

View all Ino Therapeutics devices

Submission Details

510(k) Number K052663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2005
Decision Date November 04, 2005
Days to Decision 38 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 139d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.