Cleared Traditional

K132429 - SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET (FDA 510(k) Clearance)

K132429 · Terumobct, Inc. · Gastroenterology & Urology device
Dec 2013
Decision
123d
Days
-
Risk

K132429 is an FDA 510(k) clearance for the SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA .... Classified as Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN).

Submitted by Terumobct, Inc. (Lakewood, US). The FDA issued a Cleared decision on December 6, 2013 after a review of 123 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.

Submission Details

510(k) Number K132429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2013
Decision Date December 06, 2013
Days to Decision 123 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 156d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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