Cleared Traditional

K961706 - P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR (FDA 510(k) Clearance)

K961706 · Fresenius USA, Inc. · Gastroenterology & Urology device
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Jul 1996
Decision
90d
Days
-
Risk

K961706 is an FDA 510(k) clearance for the P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 C.... Classified as Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN).

Submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on July 31, 1996 after a review of 90 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K961706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1996
Decision Date July 31, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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