Cleared Traditional

K192707 - Optiflux F180NR Dialyzer

K192707 is an FDA 510(k) clearance for Optiflux F180NR Dialyzer, manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K192707 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
360d
Days
Class 2
Risk

K192707 is an FDA 510(k) clearance for the Optiflux F180NR Dialyzer. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on September 21, 2020 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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. Elevated predicate reliance profile. 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 - K192707

510(k) Number K192707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2019
Decision Date September 21, 2020
Days to Decision 360 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
229d slower than avg
Panel avg: 131d · This submission: 360d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 294
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K192707.
Optiflux Series of Dialyzers F160NR, F180NR, F200NR
K203062 · Fresenius Medical Care Renal Therapies Group, LLC · Dec 2020
SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
K193670 · Quanta Dialysis Technologies, Ltd. · Dec 2020
Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22
K193542 · Bellco Srl · Oct 2020
DIMI RRT System
K193005 · Dialco Medical, Inc. · Aug 2020
Optiflux Enexa F500 Dialyzer
K192928 · Fresenius Medical Care Reanal Therapies Group, LLC · Jul 2020
Tablo Hemodialysis System
K200741 · Outset Medical, Inc. · Mar 2020