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

Submission Details

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
55d slower than avg
Panel avg: 130d · This submission: 185d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

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

All 12
Devices cleared under the same product code (LKN) and FDA review panel - the closest regulatory comparables to K172590.
Spectra Optia Apheresis System
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K180615 · Fresenius Kabi USA,Llc · Dec 2018
Spectra Optia Apheresis System
K181049 · Terumobct, Inc. · Nov 2018
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031
K060734 · Fresenius Medical Care North America · Sep 2006
FRESENIUS ART HEMOADSORPTION SYSTEM
K050273 · Fresenius Medical Care North America · Jun 2005
P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR
K961706 · Fresenius USA, Inc. · Jul 1996