Cleared Traditional

K842131 - FORMACLEAR- & MULTIPLE (FDA 510(k) Clearance)

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

K842131 · Rna Medical Corp. · Pathology device
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Sep 1984
Decision
103d
Days
Class 2
Risk

K842131 is an FDA 510(k) clearance for the FORMACLEAR- & MULTIPLE. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by Rna Medical Corp. (Walker, US). The FDA issued a Cleared decision on September 10, 1984 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 876.5820 - 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 Rna Medical Corp. devices

Submission Details

510(k) Number K842131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1984
Decision Date September 10, 1984
Days to Decision 103 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 77d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKQ System, Dialysate Delivery, Central Multiple Patient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Pathology devices follow this clearance model.