Cleared Traditional

K821863 - DIALYZER REPROCESSING SYSTEM DRS-4

K821863 is an FDA 510(k) clearance for DIALYZER REPROCESSING SYSTEM DRS-4, manufactured by Seratronics, Inc.. The device is a Class 2 Gastroenterology & Urology device with 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.

FDA 510(k) Submission Details - K821863

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 131d · This submission: 116d
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 K821863.
AHR-3000 RE-USE ADAPTOR
K830190 · Colorado Medical, Inc. · May 1983
RENALIN (TENTATIVE
K830575 · Renal Systems, Inc. · Mar 1983
RENATRON DIALYZER REPROCESSING SYS
K830574 · Renal Systems, Inc. · Mar 1983
ECHO, MODEL MM-1000
K821383 · Mesa Medical, Inc. · Jun 1982
AUTOMATIC DIALYZER REPROCESSOR #ADR-22
K820695 · Texas Medical Devices, Inc. · Apr 1982
COMPUDIAL/KP-1
K813107 · Computer Dialysis Systems, Inc. · Mar 1982
K821863 · DIALYZER REPROCESSING SYSTEM DRS-4
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