Cleared Traditional

K801634 - THE VITA 2 DISPOSABLE DIALYZER

K801634 is the FDA 510(k) clearance for THE VITA 2 DISPOSABLE DIALYZER by Bellco Artifidial Organ Spec., Inc.. It is a Class 2 Gastroenterology & Urology device (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.

View all Bellco Artifidial Organ Spec., Inc. devices

Submission Details

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
25d slower than avg
Panel avg: 130d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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