Cleared Traditional

K874607 - FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS (FDA 510(k) Clearance)

K874607 · Organon Teknika Corp. · Gastroenterology & Urology device
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Jan 1988
Decision
79d
Days
-
Risk

K874607 is an FDA 510(k) clearance for the FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS. Classified as Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN).

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on January 27, 1988 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K874607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1987
Decision Date January 27, 1988
Days to Decision 79 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
51d faster than avg
Panel avg: 130d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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