Cleared Traditional

BIO-CARB D16000, D16001, AND D17000 (K861646) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K861646 · Societe D' Analyses Bio-Pharmaceutiques,Inc. · Gastroenterology & Urology device
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Aug 1986
Decision
99d
Days
Class 2
Risk

K861646 is an FDA 510(k) clearance for the BIO-CARB D16000, D16001, AND D17000. Classified as Dialyzer, Disposable (product code FJH), Class II - Special Controls.

Submitted by Societe D' Analyses Bio-Pharmaceutiques,Inc. (Fort Worth, US). The FDA issued a Cleared decision on August 7, 1986 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5830 - the FDA gastroenterology and urology device framework. 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 K861646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1986
Decision Date August 07, 1986
Days to Decision 99 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
31d faster than avg
Panel avg: 130d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJH Dialyzer, Disposable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5830
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.