Cleared Traditional

K182367 - DIASAFEplusUS

K182367 is an FDA 510(k) clearance for DIASAFEplusUS, manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K182367 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2019
Decision
132d
Days
Class 2
Risk

K182367 is an FDA 510(k) clearance for the DIASAFEplusUS. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on January 10, 2019 after a review of 132 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 Fresenius Medical Care Renal Therapies Group, LLC devices

FDA 510(k) Submission Details - K182367

510(k) Number K182367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2018
Decision Date January 10, 2019
Days to Decision 132 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
1d slower than avg
Panel avg: 131d · This submission: 132d
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 71
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K182367.
U9000 Plus Ultrafilter
K211035 · Baxter Healthcare Corporation · Oct 2021
EON Portable RO Water Purification System
K200670 · Mar Cor Purification, Inc. · Apr 2020
Millenium HX
K192398 · Mar Cor Purification, Inc. · Oct 2019
EON Portable Reverse Osmosis Water Purification System
K171099 · Cantel · Jan 2018
EndoPur Filter
K161304 · Nephros, Inc. · Mar 2017
Matrix Pre-Treatment Controller
K161844 · Better Water, LLC · Dec 2016