Cleared Traditional

K874573 - FRESENIUS PURISTERIL 340 (TM)

K874573 is an FDA 510(k) clearance for FRESENIUS PURISTERIL 340 (TM), 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 172-day FDA review.

K874573 · Seratronics, Inc. · Gastroenterology & Urology device
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Apr 1988
Decision
172d
Days
Class 2
Risk

K874573 is an FDA 510(k) clearance for the FRESENIUS PURISTERIL 340 (TM). 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 25, 1988 after a review of 172 days - an extended review 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: 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 - K874573

510(k) Number K874573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1987
Decision Date April 25, 1988
Days to Decision 172 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
41d slower than avg
Panel avg: 131d · This submission: 172d
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 K874573.
RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330
K904210 · Minntech Corp. · Nov 1990
SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT
K900341 · Serim Research Corp. · Jul 1990
TRANSLUMINAL ENDARTERECTOMY DEVICE
K884154 · Thomas J. Fogarty, M.D. · Dec 1988
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
K874573 · FRESENIUS PURISTERIL 340 (TM)
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