Cleared Traditional

K832230 - DIALYZER PREPARATION SYS DPS-4

K832230 is an FDA 510(k) clearance for DIALYZER PREPARATION SYS DPS-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 95-day FDA review.

K832230 · Seratronics, Inc. · Gastroenterology & Urology device
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Oct 1983
Decision
95d
Days
Class 2
Risk

K832230 is an FDA 510(k) clearance for the DIALYZER PREPARATION SYS DPS-4. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Seratronics, Inc. (Walker, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 95 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

FDA 510(k) Submission Details - K832230

510(k) Number K832230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1983
Decision Date October 14, 1983
Days to Decision 95 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
36d faster than avg
Panel avg: 131d · This submission: 95d
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 31
Devices cleared under the same product code (LIF) and FDA review panel - the closest regulatory comparables to K832230.
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
RENALIN (TENTATIVE
K830575 · Renal Systems, Inc. · Mar 1983
RENATRON DIALYZER REPROCESSING SYS
K830574 · Renal Systems, Inc. · Mar 1983
DIALYZER REPROCESSING SYSTEM DRS-4
K821863 · Seratronics, Inc. · Oct 1982