Cleared Traditional

K945559 - MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS

K945559 is an FDA 510(k) clearance for MAR COR COMPLETE WATER TREATMENT SYSTEM..., manufactured by Mar Cor Services, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 565-day FDA review.

K945559 · Mar Cor Services, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
565d
Days
Class 2
Risk

K945559 is an FDA 510(k) clearance for the MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS. 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 May 28, 1996 after a review of 565 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - 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 Mar Cor Services, Inc. devices

FDA 510(k) Submission Details - K945559

510(k) Number K945559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1994
Decision Date May 28, 1996
Days to Decision 565 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
434d slower than avg
Panel avg: 131d · This submission: 565d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 82
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K945559.
GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
K981085 · Gambro Healthcare · May 1998
HYDRA METER
K974127 · Automata Instrumentation, Inc. · Dec 1997
PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST
K964539 · Zyzatech Water Systems, Inc. · Nov 1997
REVERSE OSMOSIS SYSTEM
K944493 · G.E.M. Water Systems · Feb 1996
PORTABLE REVERSE OSMOSIS MACHINE
K954928 · Better Water, Inc. · Jan 1996
FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS
K954349 · Minntech Corp. · Dec 1995