Cleared Traditional

K001811 - NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM

K001811 is an FDA 510(k) clearance for NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM, manufactured by Neu-Ion, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K001811 · Neu-Ion, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
132d
Days
Class 2
Risk

K001811 is an FDA 510(k) clearance for the NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Neu-Ion, Inc. (Baltimore, US). The FDA issued a Cleared decision on October 25, 2000 after a review of 132 days - within the typical 510(k) review window.

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: 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.

View all Neu-Ion, Inc. devices

FDA 510(k) Submission Details - K001811

510(k) Number K001811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2000
Decision Date October 25, 2000
Days to Decision 132 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 131d · This submission: 132d
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 99
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K001811.
PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
K994279 · Pure Water Solutions, Inc. · Dec 2000
AIW WATER SYSTEM FOR HEMODIALYSIS
K001282 · American Industrial Water · Dec 2000
SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100
K000249 · Schaefer Water Centers · Dec 2000
FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS
K991495 · Fluid Process Systems, Inc. · Aug 2000
DIALGUARD ENDOTOXIN REMOVAL DEVICE
K993806 · Clarigen, Inc. · Aug 2000
NELSON WATER SYSTEMS FOR HEMODIALYSIS
K993877 · Nelson Environmental Technologies, Inc. · May 2000