Cleared Traditional

K151368 - Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter (FDA 510(k) Clearance)

K151368 · Terumo Bct · Gastroenterology & Urology device
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Sep 2015
Decision
113d
Days
-
Risk

K151368 is an FDA 510(k) clearance for the Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connectio.... Classified as Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN).

Submitted by Terumo Bct (Lakewood, US). The FDA issued a Cleared decision on September 11, 2015 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K151368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2015
Decision Date September 11, 2015
Days to Decision 113 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 130d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Device Class -