Cleared Traditional

K854011 - RENALFO HEMOFILTER CAVHD

K854011 is the FDA 510(k) clearance for RENALFO HEMOFILTER CAVHD by Renal Systems, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K854011 · Renal Systems, Inc. · Gastroenterology & Urology device
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Nov 1985
Decision
36d
Days
Class 2
Risk

K854011 is an FDA 510(k) clearance for the RENALFO HEMOFILTER CAVHD. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Renal Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 5, 1985 after a review of 36 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Renal Systems, Inc. devices

Submission Details

510(k) Number K854011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1985
Decision Date November 05, 1985
Days to Decision 36 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 130d · This submission: 36d
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 198
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K854011.
GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS
K860938 · Gambro, Inc. · Apr 1986
GAMBRO BLOOD CONCENTRATOR SETS 16,60,200
K854309 · Gambro, Inc. · Dec 1985
HOLLOW FIBER DIALYZER
K854586 · Travenol Laboratories, S.A. · Dec 1985
FILTRAL HEMODIALYZER
K852885 · Hospal Medical Corp. · Sep 1985
DIMENSION TOTAL HIP PROSTHESIS
K853333 · Kirschner Medical Corp. · Sep 1985
RENAFLO HEMOCONCENTRATOR
K844790 · Renal Systems, Inc. · May 1985