Cleared Special

K153601 - Spectra Optia Apheresis System

K153601 · Terumobct, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Terumobct, Inc. devices

FDA 510(k) Submission Details - K153601

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 131d · This submission: 29d
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 K153601.
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
K181049 · Terumobct, Inc. · Nov 2018
Spectra Optia Apheresis System
K172590 · Terumobct, Inc. · Mar 2018
Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter
K151368 · Terumo Bct · Sep 2015
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)
K141938 · Terumobct, Inc. · Mar 2015
AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM
K141019 · Fenwal, Inc. · Jun 2014