Cleared Traditional

K042089 - NX STAGE WATER PURIFICATION SYSTEM

K042089 is an FDA 510(k) clearance for NX STAGE WATER PURIFICATION SYSTEM, manufactured by Nxstage Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K042089 · Nxstage Medical, Inc. · Gastroenterology & Urology device
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Nov 2004
Decision
113d
Days
Class 2
Risk

K042089 is an FDA 510(k) clearance for the NX STAGE WATER PURIFICATION SYSTEM. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on November 24, 2004 after a review of 113 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 Nxstage Medical, Inc. devices

FDA 510(k) Submission Details - K042089

510(k) Number K042089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2004
Decision Date November 24, 2004
Days to Decision 113 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 130d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FIP Subsystem, Water Purification

All 27
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K042089.
DIASAFEplusUS
K182367 · Fresenius Medical Care Renal Therapies Group, LLC · Jan 2019
EON Portable Reverse Osmosis Water Purification System
K171099 · Cantel · Jan 2018
WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K042797 · Gambro Renal Products · Mar 2005
DIACLEAR ULTRAFILTER
K003957 · Gambro Renal Products · Nov 2001
FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
K983126 · Minntech Corp. · Mar 1999
FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS
K954349 · Minntech Corp. · Dec 1995

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.