Cleared Traditional

K060734 - FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031

Also marketed or referenced as:
FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)
K060734 · Fresenius Medical Care North America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
169d
Days
-
Risk

K060734 is an FDA 510(k) clearance for the FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031. Classified as Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN).

Submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on September 5, 2006 after a review of 169 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 Fresenius Medical Care North America devices

FDA 510(k) Submission Details - K060734

510(k) Number K060734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2006
Decision Date September 05, 2006
Days to Decision 169 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 131d · This submission: 169d
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
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