Cleared Abbreviated

K003877 - MAR COR SERVICES SEMPER PURE RO MACHINE

K003877 is an FDA 510(k) clearance for MAR COR SERVICES SEMPER PURE RO MACHINE, manufactured by Mar Cor Services, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Abbreviated 510(k) pathway after a 189-day FDA review.

K003877 · Mar Cor Services, Inc. · Gastroenterology & Urology device
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Jun 2001
Decision
189d
Days
Class 2
Risk

K003877 is an FDA 510(k) clearance for the MAR COR SERVICES SEMPER PURE RO MACHINE. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Mar Cor Services, Inc. (Harleysville, US). The FDA issued a Cleared decision on June 22, 2001 after a review of 189 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - the FDA gastroenterology and urology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Mar Cor Services, Inc. devices

FDA 510(k) Submission Details - K003877

510(k) Number K003877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2000
Decision Date June 22, 2001
Days to Decision 189 days
Submission Type Abbreviated
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 131d · This submission: 189d
Pathway characteristics
Standards-based clearance path.

FIP Device Classification - Class 2, Special Controls

Product Code FIP Subsystem, Water Purification
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
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 - FIP Subsystem, Water Purification

All 83
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K003877.
NX STAGE WATER PURIFICATION SYSTEM
K042089 · Nxstage Medical, Inc. · Nov 2004
ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
K041163 · Isopure, Corp. · Oct 2004
DIACLEAR ULTRAFILTER
K003957 · Gambro Renal Products · Nov 2001
WATER PURIFICATION SYSTEM
K994292 · Water & Power Technologies, Inc. · Jan 2001
PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
K994279 · Pure Water Solutions, Inc. · Dec 2000
FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS
K991495 · Fluid Process Systems, Inc. · Aug 2000