Cleared Traditional

K841403 - HEMO-RO WATER PURIFICATION SYS

K841403 is an FDA 510(k) clearance for HEMO-RO WATER PURIFICATION SYS, manufactured by Millipore Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K841403 · Millipore Corp. · Gastroenterology & Urology device
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Jul 1984
Decision
94d
Days
Class 2
Risk

K841403 is an FDA 510(k) clearance for the HEMO-RO WATER PURIFICATION SYS. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Millipore Corp. (Walker, US). The FDA issued a Cleared decision on July 6, 1984 after a review of 94 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 Millipore Corp. devices

FDA 510(k) Submission Details - K841403

510(k) Number K841403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1984
Decision Date July 06, 1984
Days to Decision 94 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 130d · This submission: 94d
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 27
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K841403.
SERIM HISENSE TEST KIT
K952215 · Serim Research Corp. · Aug 1995
RENAGUARD DIALYSATE FILTER
K945136 · Minntech Corp. · Feb 1995
ASCORBIC ACID
K842215 · Organon Teknika Corp. · Aug 1984
EXTRAPURE REVERSE OSMOSIS WATER UNIT
K822385 · Extracorporeal Medical Specialities, Inc. · Oct 1982
GAMBRO WATER PURIFICATION MONITOR WRD
K811678 · Gambro, Inc. · Jul 1981
CENTRY 2 SYSTEM #016, 103, 016, 104
K791086 · Cobe Laboratories, Inc. · Jul 1979