Cleared Traditional

K141938 - SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)

K141938 · Terumobct, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2015
Decision
249d
Days
-
Risk

K141938 is an FDA 510(k) clearance for the SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD .... 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 23, 2015 after a review of 249 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 - K141938

510(k) Number K141938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2014
Decision Date March 23, 2015
Days to Decision 249 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
118d slower than avg
Panel avg: 131d · This submission: 249d
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 K141938.
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K151368 · Terumo Bct · Sep 2015
AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM
K141019 · Fenwal, Inc. · Jun 2014
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