Cleared Special

K181049 - Spectra Optia Apheresis System

K181049 · Terumobct, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Terumobct, Inc. devices

FDA 510(k) Submission Details - K181049

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 131d · This submission: 195d
Pathway characteristics
Modification to existing cleared device.

LKN Device Classification - Class 0,

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

Regulatory Peers - LKN Separator, Automated, Blood Cell And Plasma, Therapeutic

All 21
Devices cleared under the same product code (LKN) and FDA review panel - the closest regulatory comparables to K181049.
AMICUS Separator System
K192150 · Fresenius Kabi AG · Nov 2019
Spectra Optia Apheresis System
K183081 · Terumobct, Inc. · Feb 2019
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
K180615 · Fresenius Kabi USA,Llc · Dec 2018
Spectra Optia Apheresis System
K172590 · Terumobct, Inc. · Mar 2018
Spectra Optia Apheresis System
K153601 · Terumobct, Inc. · Jan 2016
Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter
K151368 · Terumo Bct · Sep 2015