Cleared Traditional

K830231 - ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES

K830231 is an FDA 510(k) clearance for ASAHI HOLLOW FIBER KIDNEYS, manufactured by Advocacy International, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K830231 · Advocacy International, Ltd. · Gastroenterology & Urology device
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Mar 1983
Decision
58d
Days
Class 2
Risk

K830231 is an FDA 510(k) clearance for the ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Advocacy International, Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1983 after a review of 58 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 Advocacy International, Ltd. devices

FDA 510(k) Submission Details - K830231

510(k) Number K830231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1983
Decision Date March 17, 1983
Days to Decision 58 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
73d faster than avg
Panel avg: 131d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOC Device Classification - Class 2, Special Controls

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 142
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K830231.
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K822339 · Extracorporeal Medical Specialities, Inc. · Feb 1983