Cleared Traditional

K842131 - FORMACLEAR- & MULTIPLE

K842131 is an FDA 510(k) clearance for FORMACLEAR- & MULTIPLE, manufactured by Rna Medical Corp.. The device is a Class 2 Pathology device with product code FKQ cleared through the Traditional 510(k) pathway after a 103-day FDA review.

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

FDA 510(k) Submission Details - K842131

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.

FKQ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FKQ System, Dialysate Delivery, Central Multiple Patient

All 36
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K842131.
NEPHROSS ALLEGRO H.F.
K844748 · Organon Teknika Corp. · Jan 1985
ST FAMILY OF HOLLOW FIBER DIALYZERS
K844756 · Travenol Laboratories, S.A. · Jan 1985
DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD
K843963 · Renal Systems, Inc. · Jan 1985
PACKETS FOR THE PREP OF DIALYSATES &
K842154 · Organon Teknika Corp. · Jul 1984
CONCENTRATE CONDUCTIVITY METER
K841543 · Renal Systems, Inc. · May 1984
RENAPAK CONCENTRATE MIXING SYS.
K840182 · Renal Systems, Inc. · May 1984