Cleared Traditional

FRESENIUS AS 104 CELL SEPARATOR (K895435) - FDA 510(k) Clearance

K895435 · Fresenius USA, Inc. · Gastroenterology & Urology device
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Nov 1990
Decision
421d
Days
-
Risk

K895435 is an FDA 510(k) clearance for the FRESENIUS AS 104 CELL SEPARATOR. Classified as Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN).

Submitted by Fresenius USA, Inc. (Concord, US). The FDA issued a Cleared decision on November 2, 1990 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Fresenius USA, Inc. devices

Submission Details

510(k) Number K895435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1989
Decision Date November 02, 1990
Days to Decision 421 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
291d slower than avg
Panel avg: 130d · This submission: 421d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Peers - LKN Separator, Automated, Blood Cell And Plasma, Therapeutic

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