Cleared Traditional

K261267 - Careflux H60

Also marketed or referenced as:
Careflux H70 Careflux V500

K261267 is the FDA 510(k) clearance for Careflux H60 by Fresenius Medical Care Renal Therapies Group, LLC. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K261267 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
99d
Days
Class 2
Risk

K261267 is an FDA 510(k) clearance for the Careflux H60. 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 July 24, 2026 after a review of 99 days - within the typical 510(k) review window.

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. 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 K261267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2026
Decision Date July 24, 2026
Days to Decision 99 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
31d faster than avg
Panel avg: 130d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 187
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K261267.
NxStage System One with NxView
K252377 · Fresenius Medical Care Renal Therapies Group, LLC · May 2026
ELISIO™-H
K260533 · Nipro Medical Corporation · Mar 2026
multiFlux 130 (F00013123)
K252459 · Fresenius Medical Care Renal Therapies Group, LLC · Feb 2026
Tablo Hemodialysis System (PN-0008000, PN-0006000U)
K253412 · Outset Medical, Inc. · Jan 2026
FX CorAL 40
K253518 · Fresenius Medical Care Renal Therapies Group, LLC · Dec 2025
Purema H Hemoconcentrator - Pediatric
K243920 · Medica USA, Inc. · Sep 2025