Cleared Traditional

K182367 - DIASAFEplusUS

K182367 is the FDA 510(k) clearance for DIASAFEplusUS by Fresenius Medical Care Renal Therapies Group, LLC. It is a Class 2 Gastroenterology & Urology device (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
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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

Submission Details

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
2d slower than avg
Panel avg: 130d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FIP Subsystem, Water Purification

All 19
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
NX STAGE WATER PURIFICATION SYSTEM
K042089 · Nxstage Medical, Inc. · Nov 2004
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
K944767 · Fresenius USA, Inc. · Nov 1995