Cleared Traditional

K082921 - RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400

K082921 · Rad Source Technologies, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
139d
Days
-
Risk

K082921 is an FDA 510(k) clearance for the RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400. Classified as Irradiator, Blood To Prevent Graft Versus Host Disease (product code MOT).

Submitted by Rad Source Technologies, Inc. (Alpharetta, US). The FDA issued a Cleared decision on February 17, 2009 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K082921

510(k) Number K082921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2008
Decision Date February 17, 2009
Days to Decision 139 days
Submission Type Traditional
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
32d slower than avg
Panel avg: 107d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

MOT Device Classification - Class 0,

Product Code MOT Irradiator, Blood To Prevent Graft Versus Host Disease
Device Class -

Regulatory Peers - MOT Irradiator, Blood To Prevent Graft Versus Host Disease

All 14
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K082921 · RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
Download PDF FDA Summary Rad Source Technologi…