Cleared Special

K192398 - Millenium HX

K192398 is the FDA 510(k) clearance for Millenium HX by Mar Cor Purification, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FIP) cleared through the Special 510(k) pathway after a 30-day FDA review.

K192398 · Mar Cor Purification, Inc. · Gastroenterology & Urology device
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Oct 2019
Decision
30d
Days
Class 2
Risk

K192398 is an FDA 510(k) clearance for the Millenium HX. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Mar Cor Purification, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 3, 2019 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mar Cor Purification, Inc. devices

Submission Details

510(k) Number K192398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2019
Decision Date October 03, 2019
Days to Decision 30 days
Submission Type Special
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
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

Cantel
Mark Arnold

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 19
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K192398.
AquaA
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K182367 · Fresenius Medical Care Renal Therapies Group, LLC · Jan 2019
EON Portable Reverse Osmosis Water Purification System
K171099 · Cantel · Jan 2018
NX STAGE WATER PURIFICATION SYSTEM
K042089 · Nxstage Medical, Inc. · Nov 2004