Cleared Traditional

K821863 - DIALYZER REPROCESSING SYSTEM DRS-4

K821863 is the FDA 510(k) clearance for DIALYZER REPROCESSING SYSTEM DRS-4 by Seratronics, Inc.. It is a Class 2 Gastroenterology & Urology device (product code LIF) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K821863 · Seratronics, Inc. · Gastroenterology & Urology device
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Oct 1982
Decision
116d
Days
Class 2
Risk

K821863 is an FDA 510(k) clearance for the DIALYZER REPROCESSING SYSTEM DRS-4. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Seratronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 18, 1982 after a review of 116 days - within the typical 510(k) review window.

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: 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 Seratronics, Inc. devices

Submission Details

510(k) Number K821863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1982
Decision Date October 18, 1982
Days to Decision 116 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 130d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (LIF) and FDA review panel - the closest regulatory comparables to K821863.
HPR HOME PATIENT RENATRON
K833181 · Renal Systems, Inc. · Oct 1983
RENALIN (TENTATIVE
K830575 · Renal Systems, Inc. · Mar 1983
RENATRON DIALYZER REPROCESSING SYS
K830574 · Renal Systems, Inc. · Mar 1983
HYDROGEN PEROXIDE TOPICAL
K820221 · Renal Systems, Inc. · Mar 1982
MODEL RS 8300
K812230 · Renal Systems, Inc. · Nov 1981