Cleared Traditional

K944539 - DRS 4 ND DIALYZER REPROCESSING SYSTEM

K944539 is the FDA 510(k) clearance for DRS 4 ND 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 440-day FDA review.

K944539 · Seratronics, Inc. · Gastroenterology & Urology device
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Nov 1995
Decision
440d
Days
Class 2
Risk

K944539 is an FDA 510(k) clearance for the DRS 4 ND DIALYZER REPROCESSING SYSTEM. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Seratronics, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on November 29, 1995 after a review of 440 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Seratronics, Inc. devices

Submission Details

510(k) Number K944539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1994
Decision Date November 29, 1995
Days to Decision 440 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
310d slower than avg
Panel avg: 130d · This submission: 440d
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 K944539.
RENACLEAR DIALYZER CLEANING SYSTEM
K991851 · Minntech Corp. · Aug 1999
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