Cleared Traditional

K801633 - THE BRAVO NEW PARALLEL FLOW DIALYZER

K801633 is an FDA 510(k) clearance for THE BRAVO NEW PARALLEL FLOW DIALYZER, manufactured by Bellco Artifidial Organ Spec., Inc.. The device is a Class 2 Gastroenterology & Urology device with 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.

FDA 510(k) Submission Details - K801633

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
25d slower than avg
Panel avg: 131d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJG Device Classification - Class 2, Special Controls

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 29
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
ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM
K801451 · Medical, Inc. · Sep 1980
LUNDIA PLATE DISP.
K800424 · Gambro, Inc. · Apr 1980
GAMBRO LUNDIA PLATE DIALYZER
K792611 · Gambro, Inc. · Feb 1980