Cleared Traditional

K833896 - BICARBOLYTE HEMO-DIAL

K833896 is the FDA 510(k) clearance for BICARBOLYTE HEMO-DIAL by Edlaw Pharmaceuticals, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K833896 · Edlaw Pharmaceuticals, Inc. · Gastroenterology & Urology device
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Jan 1984
Decision
50d
Days
Class 2
Risk

K833896 is an FDA 510(k) clearance for the BICARBOLYTE HEMO-DIAL. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Edlaw Pharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1984 after a review of 50 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Edlaw Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K833896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1983
Decision Date January 03, 1984
Days to Decision 50 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
80d faster than avg
Panel avg: 130d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOC Accessories, Blood Circuit, Hemodialysis
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 122
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K833896.
BLOOD TUBING
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EXP* 500 PARALLEL PLATE DIALYZER
K840057 · Extracorporeal Medical Specialities, Inc. · Feb 1984
EXP* 700 PARALLEL PLATE DIALYZER
K840146 · Extracorporeal Medical Specialities, Inc. · Feb 1984
NEGATIVE PRESSURE ARTERIAL BLOOD
K833905 · Erika, Inc. · Jan 1984
NEGATIVE PRESSURE VENOUS BLOOD LINE
K833906 · Erika, Inc. · Jan 1984
DUAL LUMEN NEEDLE
K833308 · Quinton, Inc. · Dec 1983