Cleared Special

K151097 - Active Breathing Coordinator

K151097 is an FDA 510(k) clearance for Active Breathing Coordinator, manufactured by Aktina Medical Corporation. The device is a Class 2 Radiology device with product code IYE cleared through the Special 510(k) pathway after a 21-day FDA review.

K151097 · Aktina Medical Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
21d
Days
Class 2
Risk

K151097 is an FDA 510(k) clearance for the Active Breathing Coordinator. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Aktina Medical Corporation (Congers, US). The FDA issued a Cleared decision on May 15, 2015 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight 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 Aktina Medical Corporation devices

FDA 510(k) Submission Details - K151097

510(k) Number K151097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2015
Decision Date May 15, 2015
Days to Decision 21 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

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