Cleared Traditional

K953681 - HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET (FDA 510(k) Clearance)

K953681 · Haemonetics Corp. · Gastroenterology & Urology device
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Jun 1996
Decision
302d
Days
-
Risk

K953681 is an FDA 510(k) clearance for the HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET. Classified as Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN).

Submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on June 4, 1996 after a review of 302 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 K953681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1995
Decision Date June 04, 1996
Days to Decision 302 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
172d slower than avg
Panel avg: 130d · This submission: 302d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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