Cleared Traditional

K801633 - THE BRAVO NEW PARALLEL FLOW DIALYZER

K801633 is the FDA 510(k) clearance for THE BRAVO NEW PARALLEL FLOW DIALYZER by Bellco Artifidial Organ Spec., Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJG) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K801633 · Bellco Artifidial Organ Spec., Inc. · Gastroenterology & Urology device
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Dec 1980
Decision
156d
Days
Class 2
Risk

K801633 is an FDA 510(k) clearance for the THE BRAVO NEW PARALLEL FLOW DIALYZER. Classified as Dialyzer, Parallel Flow (product code FJG), Class II - Special Controls.

Submitted by Bellco Artifidial Organ Spec., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1980 after a review of 156 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Bellco Artifidial Organ Spec., Inc. devices

Submission Details

510(k) Number K801633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1980
Decision Date December 18, 1980
Days to Decision 156 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 130d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJG Dialyzer, Parallel Flow
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FJG Dialyzer, Parallel Flow

All 24
Devices cleared under the same product code (FJG) and FDA review panel - the closest regulatory comparables to K801633.
COBE PPD .8
K810066 · Cobe Laboratories, Inc. · Jun 1981
EXTRACORPOREAL'S EXP 400 PARALLEL PLATE
K802364 · Extracorporeal Medical Specialities, Inc. · Jan 1981
GAMBRO LUNDIA PLATE DISP. DIALYZER
K802389 · Gambro, Inc. · Dec 1980
LUNDIA PLATE DISP.
K800424 · Gambro, Inc. · Apr 1980
GAMBRO LUNDIA PLATE DIALYZER
K792611 · Gambro, Inc. · Feb 1980
EXTRACORPOREAL'S MODEL EX-85 DIALYZER
K791961 · Extracorporeal Medical Specialities, Inc. · Nov 1979