Cleared Traditional

K801634 - THE VITA 2 DISPOSABLE DIALYZER

K801634 is an FDA 510(k) clearance for THE VITA 2 DISPOSABLE DIALYZER, manufactured by Bellco Artifidial Organ Spec., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FHS cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K801634 · Bellco Artifidial Organ Spec., Inc. · Gastroenterology & Urology device
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Dec 1980
Decision
155d
Days
Class 2
Risk

K801634 is an FDA 510(k) clearance for the THE VITA 2 DISPOSABLE DIALYZER. Classified as Dialyzer, Single Coil (product code FHS), Class II - Special Controls.

Submitted by Bellco Artifidial Organ Spec., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 17, 1980 after a review of 155 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 - K801634

510(k) Number K801634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1980
Decision Date December 17, 1980
Days to Decision 155 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
24d slower than avg
Panel avg: 131d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FHS Device Classification - Class 2, Special Controls

Product Code FHS Dialyzer, Single Coil
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 - FHS Dialyzer, Single Coil

All 11
Devices cleared under the same product code (FHS) and FDA review panel - the closest regulatory comparables to K801634.
MICROCOIL 80 DIALYZER
K812811 · Erika, Inc. · Dec 1981
MICROCOIL 150 DIALYZER
K811974 · Erika, Inc. · Sep 1981
MICRO-COIL 100 COIL DIALYZER
K800723 · Erika, Inc. · May 1980
GAMBRO LUNDIA COIL DIALYZER
K800174 · Gambro, Inc. · Feb 1980
DIALYZER, CD-800 COIL
K790223 · Travenol Laboratories, S.A. · Mar 1979
DIALYZER, DISP., COIL, LUNDIA
K781102 · Gambro, Inc. · Oct 1978