Cleared Traditional

K991495 - FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS

K991495 is an FDA 510(k) clearance for FLUID PROCESS SYSTEMS EXCHANGE CARBON A..., manufactured by Fluid Process Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 488-day FDA review.

K991495 · Fluid Process Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
488d
Days
Class 2
Risk

K991495 is an FDA 510(k) clearance for the FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMOD.... Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Fluid Process Systems, Inc. (El Paso, US). The FDA issued a Cleared decision on August 28, 2000 after a review of 488 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 Fluid Process Systems, Inc. devices

FDA 510(k) Submission Details - K991495

510(k) Number K991495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1999
Decision Date August 28, 2000
Days to Decision 488 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
357d slower than avg
Panel avg: 131d · This submission: 488d
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 K991495.
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
DIALGUARD ENDOTOXIN REMOVAL DEVICE
K993806 · Clarigen, Inc. · Aug 2000
NELSON WATER SYSTEMS FOR HEMODIALYSIS
K993877 · Nelson Environmental Technologies, Inc. · May 2000
H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K993520 · Serv-A-Pure Co. · May 2000