Cleared Traditional

K841585 - AMER. BENTLEY CONTINU-BLOOD PROCESSOR-

K841585 is an FDA 510(k) clearance for AMER. BENTLEY CONTINU-BLOOD PROCESSOR-, manufactured by American Bentley. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K841585 · American Bentley · Gastroenterology & Urology device
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Oct 1984
Decision
184d
Days
Class 2
Risk

K841585 is an FDA 510(k) clearance for the AMER. BENTLEY CONTINU-BLOOD PROCESSOR-. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by American Bentley (Irvine, US). The FDA issued a Cleared decision on October 18, 1984 after a review of 184 days - an extended review 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: 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 American Bentley devices

FDA 510(k) Submission Details - K841585

510(k) Number K841585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1984
Decision Date October 18, 1984
Days to Decision 184 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
53d slower than avg
Panel avg: 131d · This submission: 184d
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 250
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K841585.
FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40
K852251 · Seratronics, Inc. · Jul 1985
RENAFLO HEMOCONCENTRATOR
K844790 · Renal Systems, Inc. · May 1985
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L
K850866 · Erika, Inc. · Apr 1985
FRESENIUS HAEMODIALYSIS A2008
K843014 · Seratronics, Inc. · Oct 1984
HOSPAL BIOSPAL SCU/CAVH KIT
K841152 · Hospal Medical Corp. · Jul 1984
CENTRY 2000 DIALYSIS CONTROL UNIT
K840680 · Cobe Laboratories, Inc. · Apr 1984