Cleared Traditional

K831423 - THERAPEUTIC EXCHANGE SYSTEM (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K831423 · Extracorporeal Medical Specialities, Inc. · Gastroenterology & Urology device
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Jan 1984
Decision
245d
Days
Class 3
Risk

K831423 is an FDA 510(k) clearance for the THERAPEUTIC EXCHANGE SYSTEM. Classified as Columns, Immunoadsorption In Extracorporeal Systems (product code LQQ), Class III - Premarket Approval.

Submitted by Extracorporeal Medical Specialities, Inc. (Walker, US). The FDA issued a Cleared decision on January 3, 1984 after a review of 245 days - an extended review 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: High-complexity regulatory submission. High regulatory complexity 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.

View all Extracorporeal Medical Specialities, Inc. devices

Submission Details

510(k) Number K831423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1983
Decision Date January 03, 1984
Days to Decision 245 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
115d slower than avg
Panel avg: 130d · This submission: 245d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQQ Columns, Immunoadsorption In Extracorporeal Systems
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.