Cleared Traditional

K172590 - Spectra Optia Apheresis System

K172590 · Terumobct, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
185d
Days
-
Risk

K172590 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 March 2, 2018 after a review of 185 days - an extended review cycle.

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.

View all Terumobct, Inc. devices

FDA 510(k) Submission Details - K172590

510(k) Number K172590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2017
Decision Date March 02, 2018
Days to Decision 185 days
Submission Type Traditional
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
54d slower than avg
Panel avg: 131d · This submission: 185d
Pathway characteristics
Predicate-based equivalence.

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 K172590.
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
K181049 · Terumobct, Inc. · Nov 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
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)
K141938 · Terumobct, Inc. · Mar 2015