Cleared Traditional

K842258 - RENATRON

K842258 is an FDA 510(k) clearance for RENATRON, manufactured by Renal Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LIF cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K842258 · Renal Systems, Inc. · Gastroenterology & Urology device
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Jul 1984
Decision
29d
Days
Class 2
Risk

K842258 is an FDA 510(k) clearance for the RENATRON. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Renal Systems, Inc. (Walker, US). The FDA issued a Cleared decision on July 6, 1984 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K842258

510(k) Number K842258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1984
Decision Date July 06, 1984
Days to Decision 29 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 131d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIF Device Classification - Class 2, Special Controls

Product Code LIF Dialyzer Reprocessing System
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - LIF Dialyzer Reprocessing System

All 56
Devices cleared under the same product code (LIF) and FDA review panel - the closest regulatory comparables to K842258.
FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G
K850127 · Computer Dialysis Systems, Inc. · Mar 1985
WAREXIN RECOMMENDED ALTERNATIVE DIALYZ
K843520 · Mesa Medical, Inc. · Oct 1984
ADAPTOR HR-3000 REUSE
K841153 · Colorado Medical, Inc. · Jul 1984
FORMA-FAS-TEST
K833128 · Chemical Detection & Experimentation · Jun 1984
ULTRAMAX
K832705 · Medicorp, Inc. · Jun 1984
ECHO MM1000
K834447 · Mesa Medical, Inc. · Mar 1984
K842258 · RENATRON
Download PDF Renal Systems, Inc.