Cleared Traditional

K980182 - WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

K980182 is an FDA 510(k) clearance for WATER PURIFICATION SYSTEM FOR HEMODIALYSIS, manufactured by Usfilter/Ionpure, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K980182 · Usfilter/Ionpure, Inc. · Gastroenterology & Urology device
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Nov 1998
Decision
300d
Days
Class 2
Risk

K980182 is an FDA 510(k) clearance for the WATER PURIFICATION SYSTEM FOR HEMODIALYSIS. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Usfilter/Ionpure, Inc. (Lowell, US). The FDA issued a Cleared decision on November 16, 1998 after a review of 300 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: 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 Usfilter/Ionpure, Inc. devices

FDA 510(k) Submission Details - K980182

510(k) Number K980182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1998
Decision Date November 16, 1998
Days to Decision 300 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
169d slower than avg
Panel avg: 131d · This submission: 300d
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 K980182.
WATER TREATMENT SYSTEM FOR HEMODIALYSIS
K983512 · Water Vault, Inc. · Apr 1999
FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
K983126 · Minntech Corp. · Mar 1999
ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS
K981680 · Dayton Water Systems · Dec 1998
GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H
K974899 · Gambro Healthcare · Sep 1998
GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
K981085 · Gambro Healthcare · May 1998
HYDRA METER
K974127 · Automata Instrumentation, Inc. · Dec 1997