Cleared Special

K113480 - SPECTRA OPTIA APHERESIS SYSTEM

K113480 · Caridianbct, Inc.. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
58d
Days
-
Risk

K113480 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 Caridianbct, Inc.. (Lakewood, US). The FDA issued a Cleared decision on January 20, 2012 after a review of 58 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 Caridianbct, Inc.. devices

FDA 510(k) Submission Details - K113480

510(k) Number K113480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2011
Decision Date January 20, 2012
Days to Decision 58 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
73d faster than avg
Panel avg: 131d · This submission: 58d
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 22
Devices cleared under the same product code (LKN) and FDA review panel - the closest regulatory comparables to K113480.
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA EXCHANGE DISPOSABLE SET
K132429 · Terumobct, Inc. · Dec 2013
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE
K131744 · Terumobct, Inc. · Aug 2013
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE
K111702 · Fenwal, Inc. · Mar 2012
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200
K071079 · Gambro Bct, Inc. · Aug 2007
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