Cleared Traditional

K984546 - BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK (FDA 510(k) Clearance)

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

K984546 · Hemocleanse, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 1999
Decision
234d
Days
Class 2
Risk

K984546 is an FDA 510(k) clearance for the BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-10.... Classified as Apparatus, Hemoperfusion, Sorbent (product code FLD), Class II - Special Controls.

Submitted by Hemocleanse, Inc. (West Lafayette, US). The FDA issued a Cleared decision on August 13, 1999 after a review of 234 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5870 - 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.

View all Hemocleanse, Inc. devices

Submission Details

510(k) Number K984546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1998
Decision Date August 13, 1999
Days to Decision 234 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
104d slower than avg
Panel avg: 130d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FLD Apparatus, Hemoperfusion, Sorbent
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5870
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.