Cleared Traditional

K860674 - DRS-4 DIALYZER REPROCESSING SYSTEM

K860674 is an FDA 510(k) clearance for DRS-4 DIALYZER REPROCESSING SYSTEM, 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 42-day FDA review.

K860674 · Seratronics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
42d
Days
Class 2
Risk

K860674 is an FDA 510(k) clearance for the DRS-4 DIALYZER REPROCESSING SYSTEM. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Seratronics, Inc. (Concord, US). The FDA issued a Cleared decision on April 7, 1986 after a review of 42 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 - K860674

510(k) Number K860674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1986
Decision Date April 07, 1986
Days to Decision 42 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
89d faster than avg
Panel avg: 131d · This submission: 42d
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 K860674.
ADR-22 AUTOMATIC DIALYZER REPROCESSOR
K874034 · Biodynamics Corp. · Oct 1987
MODIFIED HR-3000 REUSE ADAPTOR
K870471 · Colorado Medical, Inc. · Apr 1987
HR-3000 REUSE ADAPTOR
K870689 · Colorado Medical, Inc. · Apr 1987
ULTRAMAX III, DIALYZER REPROCESSING DEVICE
K860026 · Medicorp, Inc. · Mar 1986
COBE REN NEW-D DISPENSING KIT
K853817 · Cobe Laboratories, Inc. · Oct 1985
RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS
K853413 · Alcide Corp. · Sep 1985
K860674 · DRS-4 DIALYZER REPROCESSING SYSTEM
Download PDF Seratronics, Inc.