Cleared Traditional

K860674 - DRS-4 DIALYZER REPROCESSING SYSTEM

K860674 is the FDA 510(k) clearance for DRS-4 DIALYZER REPROCESSING SYSTEM by Seratronics, Inc.. It is a Class 2 Gastroenterology & Urology device (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.

View all Seratronics, Inc. devices

Submission Details

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

Regulatory Context

Review time vs. panel average

88d faster than avg

Panel avg: 130d · This submission: 42d

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 K860674.

ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)

K970799 · Alexander Mfg. Co. · May 1997

FORMALIN REUSE CART

K941757 · National Medical Care, Medical Products Div., Inc. · Jan 1996

RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330

K904210 · Minntech Corp. · Nov 1990

COBE REN NEW-D DISPENSING KIT

K853817 · Cobe Laboratories, Inc. · Oct 1985

RENATRON

K842258 · Renal Systems, Inc. · Jul 1984

HPR HOME PATIENT RENATRON

K833181 · Renal Systems, Inc. · Oct 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K860674

Seratronics, Inc.

Concord, CA · US

SCOTT N WALKER

Regulatory profile

21 submissions 21 cleared

100% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active