Cleared Traditional

K171099 - EON Portable Reverse Osmosis Water Puri...

K171099 is an FDA 510(k) clearance for EON Portable Reverse Osmosis Water Puri..., manufactured by Cantel. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K171099 · Cantel · Gastroenterology & Urology device
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Jan 2018
Decision
267d
Days
Class 2
Risk

K171099 is an FDA 510(k) clearance for the EON Portable Reverse Osmosis Water Purification System. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Cantel (Minneapolis, US). The FDA issued a Cleared decision on January 5, 2018 after a review of 267 days - an extended review cycle.

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 Cantel devices

FDA 510(k) Submission Details - K171099

510(k) Number K171099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2017
Decision Date January 05, 2018
Days to Decision 267 days
Submission Type Traditional
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
137d slower than avg
Panel avg: 130d · This submission: 267d
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 K171099.
EON Portable RO Water Purification System
K200670 · Mar Cor Purification, Inc. · Apr 2020
Millenium HX
K192398 · Mar Cor Purification, Inc. · Oct 2019
DIASAFEplusUS
K182367 · Fresenius Medical Care Renal Therapies Group, LLC · Jan 2019
WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K042797 · Gambro Renal Products · Mar 2005
NX STAGE WATER PURIFICATION SYSTEM
K042089 · Nxstage Medical, Inc. · Nov 2004
DIACLEAR ULTRAFILTER
K003957 · Gambro Renal Products · Nov 2001