Cleared Traditional

K850621 - GAMBRO PLASMAFILTRATION SYSTEM (FDA 510(k) Clearance)

K850621 · Gambro, Inc. · Gastroenterology & Urology device
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May 1985
Decision
90d
Days
-
Risk

K850621 is an FDA 510(k) clearance for the GAMBRO PLASMAFILTRATION SYSTEM. Classified as Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN).

Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on May 16, 1985 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 K850621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1985
Decision Date May 16, 1985
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
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 -