Cleared Traditional

K851393 - DUPONT PREP FOUR-SOLVENT RETROFIT KIT (FDA 510(k) Clearance)

Class I Pathology device.

K851393 · E.I. Dupont DE Nemours & Co., Inc. · Pathology device
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Jul 1985
Decision
94d
Days
Class 1
Risk

K851393 is an FDA 510(k) clearance for the DUPONT PREP FOUR-SOLVENT RETROFIT KIT. Classified as Clinical Sample Concentrator (product code JJH), Class I - General Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on July 12, 1985 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.2310 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K851393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1985
Decision Date July 12, 1985
Days to Decision 94 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 77d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJH Clinical Sample Concentrator
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2310
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.