Cleared Special

K153601 - Spectra Optia Apheresis System (FDA 510(k) Clearance)

K153601 · Terumobct, Inc. · Gastroenterology & Urology device
Jan 2016
Decision
29d
Days
-
Risk

K153601 is an FDA 510(k) clearance for the Spectra Optia Apheresis System. 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 January 14, 2016 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. 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.

Submission Details

510(k) Number K153601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2015
Decision Date January 14, 2016
Days to Decision 29 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 156d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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