Cleared Special

K181049 - Spectra Optia Apheresis System (FDA 510(k) Clearance)

K181049 · Terumobct, Inc. · Gastroenterology & Urology device
Nov 2018
Decision
195d
Days
-
Risk

K181049 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 November 1, 2018 after a review of 195 days - an extended review 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. Standard predicate reliance. 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 K181049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2018
Decision Date November 01, 2018
Days to Decision 195 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 156d · This submission: 195d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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